The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients (ITTC Trial): A Single-Center, Prospective, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Targeted Temperature Management
- Sponsor
- Tang Ziren
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Activated Partial Thromboplastin Time (APTT)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Tang Ziren
Professor
Capital Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- The rate of bleeding-related events(4 days)
- The concentration of D-dimer (D-D)(4 days)
- Platelet Count (PLT)(4 days)
- The concentration of plasmin-α2-plasmin inhibitor complex (PIC)(4 days)
- The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC)(4 days)
- thrombelastogram (TEG)(4 days)
- CPC Score(28 days and 6 months)
- The concentration of fibrinogen (FBG)(4 days)
- The concentration of thrombomodulin (TM)(4 days)
- The concentration of thrombin-antithrombin complex (TAT)(4 days)
- The Milliliters of blood products(4 days)
- International Normalized Ratio (INR)(4 days)