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

NCT ID: NCT06543849

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Targeted Temperature Management; Cardiac Arrest; Thrombin Function; Treatment Duration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

24-hour treatment

Group Type: SHAM_COMPARATOR

Target Temperature Management Treatment

Intervention Type: PROCEDURE

Target Temperature Management Treatment

72-hour treatment

Group Type: ACTIVE_COMPARATOR

Target Temperature Management Treatment

Intervention Type: PROCEDURE

Target Temperature Management Treatment

Interventions

Target Temperature Management Treatment

Target Temperature Management Treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang Ziren

OTHER

Sponsor Role: lead

Responsible Party

Tang Ziren

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2023-1-26-5

Identifier Type: -

Identifier Source: org_study_id