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

NCT06543849 | Active Not Recruiting DMC

• 1 other identifier: 2023-1-26-5
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Prothrombin Time (PT)

  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)

  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)

  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)

  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 Outcomes (12)

• The concentration of D-dimer (D-D)

  4 days

• International Normalized Ratio (INR)

  4 days

• The concentration of plasmin-α2-plasmin inhibitor complex (PIC)

  4 days

• The concentration of fibrinogen (FBG)

  4 days

• The concentration of thrombin-antithrombin complex (TAT)

  4 days

Other Outcomes (1)

• The percentage of serious adverse events during the 4-day treatment period

  4 days

Study Arms (2)

24-hour treatment

SHAM COMPARATOR

Procedure: Target Temperature Management Treatment

72-hour treatment

ACTIVE COMPARATOR

Procedure: Target Temperature Management Treatment

Interventions

Target Temperature Management Treatment PROCEDURE

Target Temperature Management Treatment

24-hour treatment; 72-hour treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• cardiac arrest caused by irreversible factors such as trauma or poisoning;
• cardiac arrest due to terminal conditions like advanced cancer;
• uncorrected persistent cardiogenic shock, defined as a systolic blood pressure below 90 mmHg despite treatment with fluid resuscitation, vasopressors, and inotropic agents;
• pre-existing cerebrovascular disease or CT-confirmed intracerebral hemorrhage upon admission;
• pre-arrest Cerebral Performance Category (CPC) score between 3 and 5;
• bradycardia or sick sinus syndrome following the return of spontaneous circulation;
• pre-existing coagulation disorders or severe bleeding tendencies;
• pregnant or breastfeeding women, or women of childbearing age with elevated serum hCG levels;
• 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);
• determination by the principal investigator that the patient is unsuitable for the trial.

Sponsors & Collaborators

• Tang Ziren: lead

Study Sites (1)

Beijing chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: The de-identified survey data will be made available for research purposes by contacting the corresponding authors

Locations

CN (1)