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

Not Applicable

Active, not recruiting

• Conditions: Thrombin Function; Targeted Temperature Management; Cardiac Arrest; Treatment Duration
• Interventions: Procedure: Target Temperature Management Treatment

• Registration Number: NCT06543849
• Lead Sponsor: Tang Ziren

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Study Start: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
72-hour treatment	Target Temperature Management Treatment	-
24-hour treatment	Target Temperature Management Treatment	-

Primary Outcome Measures

Name	Time	Method
Activated Partial Thromboplastin Time (APTT)	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.
Prothrombin Activity (PA)	4 days	The primary outcome measure is the statistical differences in prothrombin activity (PA) between the two groups of patients at various time points.
Prothrombin Time (PT)	4 days	The primary outcome measure is the statistical differences in prothrombin time (PT) between the two groups of patients at various time points.
Thrombin Time (TT)	4 days	The primary outcome measure is the statistical differences in thrombin time (TT) between the two groups of patients at various time points.

Secondary Outcome Measures

Name	Time	Method
The concentration of D-dimer (D-D)	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.
The rate of bleeding-related events	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.
The concentration of plasmin-α2-plasmin inhibitor complex (PIC)	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.
The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC)	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.
thrombelastogram (TEG)	4 days	The primary outcome measure is the statistical differences in thrombelastogram (TEG) between the two groups of patients at various time points.
CPC Score	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.
The concentration of fibrinogen (FBG)	4 days	The primary outcome measure is the statistical differences in fibrinogen (FBG) between the two groups of patients at various time points.
The concentration of thrombomodulin (TM)	4 days	The primary outcome measure is the statistical differences in thrombomodulin (TM) between the two groups of patients at various time points.
The concentration of thrombin-antithrombin complex (TAT)	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.
Platelet Count (PLT)	4 days	The primary outcome measure is the statistical differences in platelet count (PLT) between the two groups of patients at various time points.
The Milliliters of blood products	4 days	The usage of blood products, including red blood cells, platelets, and fresh frozen plasma.
International Normalized Ratio (INR)	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.

Trial Locations

Locations (1)

Beijing chao-yang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China