Nurse-Led Predictive Protocol Cuts Neuro-Endovascular Complications

December 12, 2025 updated by: Zhigang Lan, West China Hospital

Vascular Endovascular Therapy: A Nurse-Led Predictive Nursing Protocol for Neurological Complications-Development, Validation, and Clinical Impact

The goal of this prospective cohort study was to develop and test a 12-item, nurse-led predictive checklist that can quickly identify patients at high risk for neurological complications (bleeding, re-blockage, brain swelling, etc.) after endovascular therapy (EVT) for stroke or unruptured aneurysms. The main questions it aims to answer are:

Does the checklist accurately flag complications (sensitivity/specificity)? Does its use shorten the time between first abnormal sign and physician action? Does it lower the rate of severe complications or death and shorten hospital stay? Researchers compared 213 patients managed with the checklist (intervention group) to 213 patients who received standard nursing observation (control group).

Participants were:

Assessed by nurses at 6, 12, 24, and 48 hours post-EVT with the checklist (intervention) or usual monitoring (control) Followed for 7 days for any neurological complication and for 30 days for severe outcomes Checked with urgent CT/MRI and treated whenever the checklist score indicated high risk (≥4/12 points)

Study Overview

Status

Status

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

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.

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 (Actual)

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.
426

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 Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years old, underwent EVT for AIS (due to anterior circulation large vessel occlusion) or UIAs (size ≥5 mm)

    • had a postoperative stay of ≥48 hours.

Exclusion Criteria:

  • preprocedural intracranial hemorrhage;
  • severe liver or kidney dysfunction;
  • coagulation disorders;
  • refusal to participate in the study.

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: Screening
  • 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: Intervention Group
Nurses used the predictive checklist to assess patients at 6 hours, 12 hours, 24 hours, and 48 hours postprocedural. For each assessment, items were scored as "positive" (1 point) or "negative" (0 point). A total score ≥4 points was defined as high risk, triggering immediate actions: (1) increased monitoring frequency (vital signs every 15 minutes, neurological assessment every 1 hour); (2) urgent cranial CT/MRI scan; (3) notification of the neurointerventional team within 10 minutes; (4) initiation of targeted interventions (e.g., blood pressure control, anti-edema therapy) as per protocol.
Other: predictive checklist
Nurses used the predictive checklist to assess patients at 6 hours, 12 hours, 24 hours, and 48 hours postprocedural. For each assessment, items were scored as "positive" (1 point) or "negative" (0 point). A total score ≥4 points was defined as high risk, triggering immediate actions: (1) increased monitoring frequency (vital signs every 15 minutes, neurological assessment every 1 hour); (2) urgent cranial CT/MRI scan; (3) notification of the neurointerventional team within 10 minutes; (4) initiation of targeted interventions (e.g., blood pressure control, anti-edema therapy) as per protocol.
No Intervention: Control group
Patients received standard post-EVT care, including vital sign monitoring (every 15-30 minutes for the first 6 hours, then every 1-2 hours), neurological assessment (every 4 hours), and routine laboratory and imaging examinations (e.g., cranial CT at 24 hours postprocedural). Nurses documented clinical findings in electronic medical records and notified physicians only when obvious abnormalities were detected (e.g., NIHSS score increase ≥4 points, severe hypertension).

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
AUC of the checklist
Time Frame: 7 days
AUC of the checklist for predicting any neurological complication (HT, reocclusion, MCE, sICH) within 7 days postprocedural. Complications were diagnosed by neurointerventional physicians based on clinical manifestations and imaging findings (CT/MRI).
7 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
30-day mortality
Time Frame: 30 days
30 days
length of hospital stay
Time Frame: 30 days
30 days
incidence of severe complications
Time Frame: 30 days
incidence of severe complications (defined as complications requiring surgical intervention, mechanical ventilation, or leading to death within 30 days);
30 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.
West China Hospital

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.
January 1, 2022

Primary Completion (Actual)

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.
December 30, 2023

Study Completion (Actual)

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.
December 30, 2023

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).
December 2, 2025

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.
December 12, 2025

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.
December 26, 2025

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.
December 26, 2025

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.
December 12, 2025

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.
December 1, 2025

More Information

Terms related to this study

Keywords

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.
  • WestChinaH-HX-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol and informed consent

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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