Clinical trial NCT06543849: The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients
Official title: The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients (ITTC Trial): A Single-Center, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Targeted Temperature Management
Cardiac Arrest
Thrombin Function
Treatment Duration
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Prothrombin Time (PT)
timeFrame: 4 days
measure: Prothrombin Activity (PA)
timeFrame: 4 days
measure: Activated Partial Thromboplastin Time (APTT)
timeFrame: 4 days
measure: Thrombin Time (TT)
timeFrame: 4 days
Secondary outcomes:
measure: The concentration of D-dimer (D-D)
timeFrame: 4 days
measure: International Normalized Ratio (INR)
timeFrame: 4 days
measure: The concentration of plasmin-α2-plasmin inhibitor complex (PIC)
timeFrame: 4 days
measure: The concentration of fibrinogen (FBG)
timeFrame: 4 days
measure: The concentration of thrombin-antithrombin complex (TAT)
timeFrame: 4 days
measure: The concentration of thrombomodulin (TM)
timeFrame: 4 days
measure: The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC)
timeFrame: 4 days
measure: thrombelastogram (TEG)
timeFrame: 4 days
measure: Platelet Count (PLT)
timeFrame: 4 days
measure: The rate of bleeding-related events
timeFrame: 4 days
measure: The Milliliters of blood products
timeFrame: 4 days
measure: CPC Score
timeFrame: 28 days and 6 months
Other outcomes:
measure: The percentage of serious adverse events during the 4-day treatment period
timeFrame: 4 days
Locations:
city: Beijing
country: China
facility: Beijing chao-yang Hospital, Capital Medical University
state: Beijing
Study officials:
References: