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

The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients (ITTC Trial): A Single-Center, Prospective, Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Arrest; Targeted Temperature Management; Treatment Duration; Thrombin Function
• Intervention / Treatment: Procedure: Target Temperature Management Treatment

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing CHAO-YANG Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 24-hour treatment	Procedure: Target Temperature Management Treatment; Target Temperature Management Treatment
Active Comparator: 72-hour treatment	Procedure: Target Temperature Management Treatment; Target Temperature Management Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
thrombelastogram (TEG)	The primary outcome measure is the statistical differences in thrombelastogram (TEG) between the two groups of patients at various time points.	4 days
The Milliliters of blood products	The usage of blood products, including red blood cells, platelets, and fresh frozen plasma.	4 days
The concentration of D-dimer (D-D)	The primary outcome measure is the statistical differences in D-dimer (D-D) between the two groups of patients at various time points.	4 days
International Normalized Ratio (INR)	The primary outcome measure is the statistical differences in international normalized ratio (INR) between the two groups of patients at various time points.	4 days
The concentration of plasmin-α2-plasmin inhibitor complex (PIC)	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.	4 days
The concentration of fibrinogen (FBG)	The primary outcome measure is the statistical differences in fibrinogen (FBG) between the two groups of patients at various time points.	4 days
The concentration of thrombin-antithrombin complex (TAT)	The primary outcome measure is the statistical differences in thrombin-antithrombin complex (TAT) between the two groups of patients at various time points.	4 days
The concentration of thrombomodulin (TM)	The primary outcome measure is the statistical differences in thrombomodulin (TM) between the two groups of patients at various time points.	4 days
The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC)	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.	4 days
Platelet Count (PLT)	The primary outcome measure is the statistical differences in platelet count (PLT) between the two groups of patients at various time points.	4 days
The rate of bleeding-related events	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.	4 days
CPC Score	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.	28 days and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of serious adverse events during the 4-day treatment period	The primary safety measure is the percentage of serious adverse events during the 4-day treatment period, including any events that cause permanent damage to organs, are life-threatening, or result in death.	4 days

Collaborators and Investigators

• Sponsor: Tang Ziren

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest
• Other Study ID Numbers: 2023-1-26-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: The de-identified survey data will be made available for research purposes by contacting the corresponding authors
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No