Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial) (ANDES platform)

September 21, 2026 updated by: Second Affiliated Hospital of Wenzhou Medical University

Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial): A Pragmatic Multi-arm, Adaptive, Open Label, Multicenter Randomized Controlled Platform Trial to Assess the Effect of Different Enhanced Anesthesia Technique in Perioperative Neurocognitive Function, as Compared to Standard Anesthesia Care in the Elderly Patients Undergoing Hip Fracture

The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture. The trial evaluates whether enhanced anesthesia techniques reduce perioperative neurocognitive disorders compared with standard anesthesia care.

The platform includes two randomization processes. In the first randomization, eligible participants are assigned to an active platform intervention-currently a preoperative regional nerve block or perioperative intravenous lidocaine infusion-or to a shared standard-anesthesia control. Participants for whom general anesthesia is planned may also enter a second, nested randomization and are assigned in a fixed 1:1 ratio to total intravenous anesthesia or volatile inhalational anesthesia, regardless of whether they participate in the first randomization.

A non-surgical cognitive control cohort is included to characterize changes in cognitive test performance over time without exposure to surgery or study interventions. The Data Monitoring Committee reviews accumulating trial data and makes recommendations to the Trial Steering Committee, which determines whether platform interventions should continue, be modified, advance, or stop.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The ANDES Platform Trial is a pragmatic, multicenter, adaptive platform trial designed to evaluate anesthesia strategies for reducing perioperative neurocognitive disorders in older patients undergoing hip fracture surgery.

The trial includes two related randomization processes.

In the first randomization, participants who meet the eligibility criteria for a specific platform intervention are randomly assigned to that intervention or to shared standard anesthesia care. The current platform interventions include preoperative regional nerve block and perioperative intravenous lidocaine infusion. Each intervention is compared with control participants who were eligible for randomization to that intervention.

Participants for whom the responsible anesthesiologist plans to use general anesthesia may enter a second, nested randomization, irrespective of their participation in the first randomization. These participants are assigned in a fixed 1:1 ratio to one of two anesthetic-maintenance strategies: total intravenous anesthesia, for which propofol-based maintenance is recommended, or volatile anesthesia, for which maintenance mainly with sevoflurane or isoflurane is recommended following intravenous induction.

Patients and treating clinicians are not blinded because of the nature of the interventions. Where implemented as specified in the protocol, outcome assessors remain unaware of treatment allocation, and statistical analyses are conducted using blinded treatment codes.

The study also includes a non-surgical cognitive control cohort. Members of this cohort do not undergo study randomization and do not receive any trial intervention. The cohort is used to help characterize changes associated with repeated cognitive testing and changes in cognition over time in the absence of surgery.

The platform allows interventions to be introduced, modified, advanced, or discontinued in accordance with the master protocol and applicable intervention-specific subprotocols. Accumulating safety and effectiveness data are reviewed by the independent Data Monitoring Committee. The committee makes recommendations to the Trial Steering Committee, which is responsible for platform decisions in accordance with the prespecified adaptive decision framework.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1860

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Dongyang, Zhejiang, China
        • Enrolling by invitation
        • Dongyang People's Hospital
      • Hangzhou, Zhejiang, China
        • Enrolling by invitation
        • Zhejiang Provincial People's Hospital
      • Jinhua, Zhejiang, China
        • Recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
      • Lishui, Zhejiang, China
      • Lishui, Zhejiang, China
        • Recruiting
        • Lishui Central Hospital, the Fifth Hospital Affiliated to Wenzhou Medical University
        • Contact:
      • Ningbo, Zhejiang, China
      • Ningbo, Zhejiang, China
      • Quzhou, Zhejiang, China
        • Recruiting
        • Quzhou People's Hospital
        • Contact:
      • Taizhou, Zhejiang, China
        • Enrolling by invitation
        • Taizhou Central Hospital
      • Taizhou, Zhejiang, China
        • Enrolling by invitation
        • Zhejiang Taizhou Hospital
      • Wenling, Zhejiang, China
        • Recruiting
        • The First People's Hospital of Wenling
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Contact:
        • Principal Investigator:
          • Ting Li, PhD
        • Sub-Investigator:
          • Bingwu Huang, PhD
      • Wenzhou, Zhejiang, China, 325000
        • Enrolling by invitation
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 65 years and older.
  2. Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
  3. American Society of Anesthesiologists (ASA) physical status IV or below.
  4. The patients or family members provide written informed consent.
  5. Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Exclusion Criteria:

  1. Patients with multiple trauma or fractures (excluding trauma that the researcher judges will not affect the patient's overall recovery, such as simple spinal compression fractures, mild soft tissue contusions, fractures of hands and feet, etc.);
  2. Two or more anesthetic surgeries are required.
  3. Patients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
  4. Patients who the researcher believes are unable to complete the assessment of primary outcome;
  5. Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Additional exclusion criteria for the nerve block randomization:

  1. Contraindications to nerve block, including allergy to local anesthetics, other contraindications specified in the applicable prescribing information, infection at the puncture site, or refusal to receive nerve block;
  2. The investigator considers the participant unsuitable for nerve block because of conditions such as a history of severe peripheral neuropathy or severe coagulation dysfunction;
  3. Receipt of nerve block before randomization during the current hospitalization.

Additional exclusion criteria for the intravenous lidocaine randomization:

  1. Allergy to lidocaine;
  2. Severe hepatic impairment or renal insufficiency for which the investigator considers the participant unsuitable for enrollment.

Eligibility Criteria for nonsurgical cognitive control participants:

A nonsurgical cognitive control cohort may be recruited from emergency departments, outpatient clinics, inpatient wards, or the community for standardization of neurocognitive assessments. These participants will be matched as far as possible to surgical participants by age and education level. Except for criteria related to hip fracture surgery and trial interventions, the same general inclusion and exclusion criteria will apply. Nonsurgical cognitive control participants must not undergo surgery or anesthesia during the observation period; participants who undergo surgery during follow-up will be excluded from the nonsurgical cognitive control cohort.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nerve block

Participants receive standard anesthesia care plus preoperative regional nerve block, as described in sub-trial protocol 1. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance.
Procedure: Nerve block

Participants receive a preoperative regional nerve block as soon as possible after randomization. Ultrasound guidance is recommended, and fascia iliaca block is the recommended block technique.

Procedure: Standard anesthesia care

Standard anesthesia care consists of routine general or regional anesthesia according to usual practice at each study center. Participants randomized to the shared control group do not receive protocol-specified trial interventions unless otherwise required by the Trial Steering Committee. Changes to standard anesthesia care are made in accordance with the prespecified adaptive decision framework. The independent Data Monitoring Committee reviews accumulating data and makes recommendations to the Trial Steering Committee, which makes the final platform decisions.

Drug: Bupivacaine liposome

For participants randomized to the nerve block group, 1.33% bupivacaine liposome is recommended as a long-acting local anesthetic, with a maximum dose not exceeding 133 mg, to maintain the continuity of the nerve block effect.

Drug: Regular local anesthetic

For participants randomized to the nerve block group, regular local anesthetic, such as bupivacaine or ropivacaine, may be used with continuous electronic analgesic pump infusion or multiple single injections to maintain the continuity of the nerve block effect.

Procedure: Total intravenous anesthesia maintenance

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to total intravenous anesthesia maintenance in a 1:1 ratio. Total intravenous anesthesia maintenance is recommended to be mainly propofol-based, and analgesics such as remifentanil or fentanyl are recommended.

Procedure: Volatile anesthesia maintenance

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to volatile anesthesia maintenance in a 1:1 ratio. Following intravenous induction, anesthesia maintenance mainly with sevoflurane or isoflurane is recommended.
Experimental: Intravenous infusion of lidocaine

Participants receive standard anesthesia care plus perioperative intravenous lidocaine infusion, as described in sub-trial protocol 2. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance.
Procedure: Standard anesthesia care

Standard anesthesia care consists of routine general or regional anesthesia according to usual practice at each study center. Participants randomized to the shared control group do not receive protocol-specified trial interventions unless otherwise required by the Trial Steering Committee. Changes to standard anesthesia care are made in accordance with the prespecified adaptive decision framework. The independent Data Monitoring Committee reviews accumulating data and makes recommendations to the Trial Steering Committee, which makes the final platform decisions.

Procedure: Total intravenous anesthesia maintenance

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to total intravenous anesthesia maintenance in a 1:1 ratio. Total intravenous anesthesia maintenance is recommended to be mainly propofol-based, and analgesics such as remifentanil or fentanyl are recommended.

Procedure: Volatile anesthesia maintenance

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to volatile anesthesia maintenance in a 1:1 ratio. Following intravenous induction, anesthesia maintenance mainly with sevoflurane or isoflurane is recommended.

Drug: Intravenous infusion of lidocaine

Participants randomized to the lidocaine group receive ECG monitoring, oxygen saturation monitoring, blood pressure monitoring, and an open intravenous route on the morning of surgery. It is recommended to start the infusion of lidocaine as soon as possible in the ward. A portable electronic infusion pump is recommended for drug delivery. The loading dose is 1 mg/kg, and the maintenance dose range is 1 to 2 mg/kg/h. The specific dose is determined by the anesthesiologist according to the patient's condition. The infusion ends when the patient leaves the post-anesthesia care unit after surgery, and the infusion time and total amount are recorded. Intravenous infusion of lidocaine should be administered under ECG monitoring.
Active Comparator: Shared standard anesthesia care

Participants receive standard anesthesia care. Participants for whom general anesthesia is planned may also enter the second nested randomization and be assigned in a fixed 1:1 ratio to total intravenous anesthesia maintenance or volatile anesthesia maintenance.
Procedure: Standard anesthesia care

Standard anesthesia care consists of routine general or regional anesthesia according to usual practice at each study center. Participants randomized to the shared control group do not receive protocol-specified trial interventions unless otherwise required by the Trial Steering Committee. Changes to standard anesthesia care are made in accordance with the prespecified adaptive decision framework. The independent Data Monitoring Committee reviews accumulating data and makes recommendations to the Trial Steering Committee, which makes the final platform decisions.

Procedure: Total intravenous anesthesia maintenance

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to total intravenous anesthesia maintenance in a 1:1 ratio. Total intravenous anesthesia maintenance is recommended to be mainly propofol-based, and analgesics such as remifentanil or fentanyl are recommended.

Procedure: Volatile anesthesia maintenance

Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to volatile anesthesia maintenance in a 1:1 ratio. Following intravenous induction, anesthesia maintenance mainly with sevoflurane or isoflurane is recommended.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
Time Frame: during the first 7 postoperative days

Neurocognitive Disorders includes:

  1. Postoperative delirium (POD) was mesaured by 3D-CAM;
  2. Neurocognitive decline was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, and active report of patients or family members).

Neurocognitive function is assessed at screening, postoperative day 3, and postoperative day 7. If discharge occurs on postoperative day 5 or 6, the final assessment is performed on the day of discharge; if discharge occurs on postoperative day 4, no repeat cognitive assessment is performed. A participant with postoperative delirium and/or postoperative neurocognitive decline is classified as positive for the primary outcome.
during the first 7 postoperative days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of hospitalization
Time Frame: days from admission to discharge, an average of 7 days
days from admission to discharge, an average of 7 days
Days at home up to 30 days after surgery (DAH30)
Time Frame: up to 30 days after surgery
up to 30 days after surgery
1-year all-cause mortality
Time Frame: 1-year after surgery
1-year after surgery
Subtypes, severity, and duration of delirium
Time Frame: during the first 7 postoperative days

Using CAM-S, and in units of days from the onset of delirium symptoms to the disappearance of symptoms or when the patient is discharged.
during the first 7 postoperative days
Neurocognitive decline in postoperative 7 days
Time Frame: during the first 7 postoperative days

Neurocognitive decline was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members.
during the first 7 postoperative days
Delayed neurocognitive recovery during 30 postoperative days
Time Frame: Postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, and postoperative day 30 ± 7 days.

This was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive domains(1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members.
Postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, and postoperative day 30 ± 7 days.
Hospital Anxiety and Depression Scale (HADs)
Time Frame: At screening, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative month 12 ± 1 month.
At screening, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative month 12 ± 1 month.
Acute pain before and after surgery
Time Frame: Before surgery and on postoperative days 1, 2, and 3.

Using Visual Analogue Scale (VAS)
Before surgery and on postoperative days 1, 2, and 3.
Incidence of important intraoperative adverse events requiring treatment
Time Frame: During anesthesia on the day of surgery.

Important intraoperative adverse events are defined as adverse events requiring treatment.
During anesthesia on the day of surgery.
Complications (except cognitive impairment)
Time Frame: during postoperation 30 days

including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc.
during postoperation 30 days
In-hospital and 30-day mortality
Time Frame: During hospitalization and within 30 days after surgery.
During hospitalization and within 30 days after surgery.
Score of EuroQol Five Dimensions Questionnaire (EQ-5D)
Time Frame: 1 week before fracture (retrospective assessment), and 1, 3, 6, 9, and 12 months after surgery.

Quality of life will be assessed using the EuroQol Five Dimensions Questionnaire (EQ-5D). Prefracture quality of life will be assessed retrospectively for the week before fracture.
1 week before fracture (retrospective assessment), and 1, 3, 6, 9, and 12 months after surgery.
Incidence of postoperative Neurocognitive Disorders (NCD)
Time Frame: Up to 12 months after surgery.

Postoperative neurocognitive disorder will be determined as a binary outcome according to the prespecified neurocognitive assessment framework. Cognitive assessments, including the Mini-Mental State Examination, Montreal Cognitive Assessment, multidomain neuropsychological tests, and patient- or caregiver-reported cognitive change, will be integrated according to the prespecified criteria to determine whether postoperative neurocognitive disorder is present. The reported outcome is the proportion of participants with postoperative neurocognitive disorder.
Up to 12 months after surgery.
Severity of postoperative Neurocognitive Disorders (NCD)
Time Frame: At 12 months after surgery
At 12 months after surgery
Type of postoperative Neurocognitive Disorders (NCD)
Time Frame: within 1 year after surgery (long-term)

Using Hachinski Ischemic Scale (HIS) combined with clinical symptoms and auxiliary examination to mesaure the type of postoperative NCD. HIS ≥7 was considered as vascular cognitive impairment.
within 1 year after surgery (long-term)
Instrumental Activities of Daily Living (IADL)
Time Frame: At screening for the week before fracture, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative months 3, 6, 9, and 12.
At screening for the week before fracture, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative months 3, 6, 9, and 12.
Health economic outcomes
Time Frame: During hospitalization; from hospital discharge to the 1-month follow-up; and for each interval from the previous follow-up visit to the 3-, 6-, 9-, and 12-month follow-up visits.

Health economic outcomes include direct medical costs, direct nonmedical costs, and indirect costs. Direct medical costs include anesthesia and related costs, surgical treatment costs, medication and biological product costs, diagnosis-related costs, supportive treatment costs, rehabilitation costs, blood and blood product costs, and consumable material costs. Direct nonmedical costs include paid caregiver costs, transportation costs, and accommodation costs related to medical care. Indirect costs mainly include productivity losses of family members or unpaid caregivers due to accompanying or caring for the participant.
During hospitalization; from hospital discharge to the 1-month follow-up; and for each interval from the previous follow-up visit to the 3-, 6-, 9-, and 12-month follow-up visits.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: From enrollment to hospital discharge, an average of 7 days.

We will collect the following known potential risks of general and local anesthesia from the start of the intervention to the subject's discharge and assess the overall incidence:

  1. cardiopulmonary resuscitation;
  2. Malignant hyperthermia or anaphylaxis;
  3. Aspiration pneumonia ; 4. Epidural hematoma requiring surgical intervention within 24 hours after regional anesthesia; 5. Lower-limb paralysis lasting more than 24 hours after regional anesthesia or nerve block; 6. Unplanned postoperative mechanical ventilation lasting more than 6 hours in patients who did not require mechanical ventilation before surgery; 7. Other adverse events during postoperative hospitalization.
From enrollment to hospital discharge, an average of 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Wenzhou Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Provincial People's Hospital
Jinhua Municipal Central Hospital
First Affiliated Hospital of Wenzhou Medical University
Taizhou Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Ningbo No.2 Hospital
People's Hospital of Quzhou
Lishui Country People's Hospital
Affiliated Wenling Hospital of Wenzhou Medical University
Dongyang People's Hospital
Ningbo No.6 Hospital
The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ting Li, MD, PhD, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAHoWMU-CR2024-03-112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Within 1 year after study completion, study data and related documentation will be made available upon request to the principal investigator or data coordinating center. The documentation will include annotated case report forms, descriptions of the structure, variables, and content of each dataset, the final protocol, study procedures, data collection forms, descriptions of variable recoding, and lists and links to major publications. Key datasets will be archived as appropriate.

IPD Sharing Time Frame

Available within 1 year after study completion.

IPD Sharing Access Criteria

Requests should be submitted to the principal investigator or data coordinating center.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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