The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients (ITTC)

April 10, 2025 updated by: Tang Ziren

The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients (ITTC Trial): A Single-Center, Prospective, Randomized Controlled Trial

This study will be a single-center, prospective, randomized controlled trial with an estimated sample size of 64 patients. Eligible patients will be randomly assigned in a 1:1 ratio to receive TTM for either 24 hours or 72 hours. The primary outcome measure will be the changes in thrombin function indices at various time points during TTM treatment in both groups. The secondary endpoints of the study include additional coagulation function indicators, the incidence of bleeding-related events between the two groups, the amount of blood products used, the incidence of thrombotic events, and the CPC scores at 28 days and 6 months for both groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.

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.
64

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
    • Beijing
      • Beijing, Beijing, China
        • Beijing Chao-Yang Hospital, Capital 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age between 18 and 80 years;
  2. Glasgow Coma Scale score of less than 8 upon admission;
  3. patients resuscitated after out-of-hospital cardiac arrest; and (4) patient or their legal representative has signed the informed consent form.

Exclusion Criteria:

  1. cardiac arrest caused by irreversible factors such as trauma or poisoning;
  2. cardiac arrest due to terminal conditions like advanced cancer;
  3. uncorrected persistent cardiogenic shock, defined as a systolic blood pressure below 90 mmHg despite treatment with fluid resuscitation, vasopressors, and inotropic agents;
  4. pre-existing cerebrovascular disease or CT-confirmed intracerebral hemorrhage upon admission;
  5. pre-arrest Cerebral Performance Category (CPC) score between 3 and 5;
  6. bradycardia or sick sinus syndrome following the return of spontaneous circulation;
  7. pre-existing coagulation disorders or severe bleeding tendencies;
  8. pregnant or breastfeeding women, or women of childbearing age with elevated serum hCG levels;
  9. presence of treatment limitations (such as refusal by the patient or legal representative to undergo advanced life support, including mechanical ventilation, chest compressions, or targeted temperature management);
  10. determination by the principal investigator that the patient is unsuitable for the trial.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Sham Comparator: 24-hour treatment
Procedure: Target Temperature Management Treatment
Target Temperature Management Treatment
Active Comparator: 72-hour treatment
Procedure: Target Temperature Management Treatment
Target Temperature Management Treatment

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
Prothrombin Time (PT)
Time Frame: 4 days
The primary outcome measure is the statistical differences in prothrombin time (PT) between the two groups of patients at various time points.
4 days
Prothrombin Activity (PA)
Time Frame: 4 days
The primary outcome measure is the statistical differences in prothrombin activity (PA) between the two groups of patients at various time points.
4 days
Activated Partial Thromboplastin Time (APTT)
Time Frame: 4 days
The primary outcome measure is the statistical differences in activated partial thromboplastin time (APTT) between the two groups of patients at various time points.
4 days
Thrombin Time (TT)
Time Frame: 4 days
The primary outcome measure is the statistical differences in thrombin time (TT) between the two groups of patients at various time points.
4 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
thrombelastogram (TEG)
Time Frame: 4 days
The primary outcome measure is the statistical differences in thrombelastogram (TEG) between the two groups of patients at various time points.
4 days
The Milliliters of blood products
Time Frame: 4 days
The usage of blood products, including red blood cells, platelets, and fresh frozen plasma.
4 days
The concentration of D-dimer (D-D)
Time Frame: 4 days
The primary outcome measure is the statistical differences in D-dimer (D-D) between the two groups of patients at various time points.
4 days
International Normalized Ratio (INR)
Time Frame: 4 days
The primary outcome measure is the statistical differences in international normalized ratio (INR) between the two groups of patients at various time points.
4 days
The concentration of plasmin-α2-plasmin inhibitor complex (PIC)
Time Frame: 4 days
The primary outcome measure is the statistical differences in plasmin-α2-plasmin inhibitor complex (PIC) between the two groups of patients at various time points.
4 days
The concentration of fibrinogen (FBG)
Time Frame: 4 days
The primary outcome measure is the statistical differences in fibrinogen (FBG) between the two groups of patients at various time points.
4 days
The concentration of thrombin-antithrombin complex (TAT)
Time Frame: 4 days
The primary outcome measure is the statistical differences in thrombin-antithrombin complex (TAT) between the two groups of patients at various time points.
4 days
The concentration of thrombomodulin (TM)
Time Frame: 4 days
The primary outcome measure is the statistical differences in thrombomodulin (TM) between the two groups of patients at various time points.
4 days
The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC)
Time Frame: 4 days
The primary outcome measure is the statistical differences in tissue-type plasminogen activator inhibitor complex (T-PAIC) between the two groups of patients at various time points.
4 days
Platelet Count (PLT)
Time Frame: 4 days
The primary outcome measure is the statistical differences in platelet count (PLT) between the two groups of patients at various time points.
4 days
The rate of bleeding-related events
Time Frame: 4 days
The incidence of bleeding-related events in the two groups of patients, including gastric occult blood, fecal occult blood, intracerebral hemorrhage, or bleeding in other organs.
4 days
CPC Score
Time Frame: 28 days and 6 months
CPC = Cerebral Performance Category Score. The Secondary Outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.
28 days and 6 months

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
The percentage of serious adverse events during the 4-day treatment period
Time Frame: 4 days
The primary safety measure is the percentage of serious adverse events during the 4-day treatment period, including any events that cause permanent damage to organs, are life-threatening, or result in death.
4 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.
Tang Ziren

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.
December 1, 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.
December 31, 2025

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.
December 31, 2025

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).
August 1, 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.
August 5, 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.
August 9, 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.
April 11, 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.
April 10, 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.
April 1, 2025

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.
  • 2023-1-26-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

The de-identified survey data will be made available for research purposes by contacting the corresponding authors

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • CSR

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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