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NCT Number: NCT06543849

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

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.

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Key information

Conditions

Targeted Temperature Management Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Thrombin Function Treatment Duration

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Target Temperature Management Treatment

Procedure

Target Temperature Management Treatment

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. The concentration of D-dimer (D-D)

    Time frame: 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.

  2. International Normalized Ratio (INR)

    Time frame: 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.

  3. The concentration of plasmin-α2-plasmin inhibitor complex (PIC)

    Time frame: 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.

  4. The concentration of fibrinogen (FBG)

    Time frame: 4 days

    The primary outcome measure is the statistical differences in fibrinogen (FBG) between the two groups of patients at various time points.

  5. The concentration of thrombin-antithrombin complex (TAT)

    Time frame: 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.

  6. The concentration of thrombomodulin (TM)

    Time frame: 4 days

    The primary outcome measure is the statistical differences in thrombomodulin (TM) between the two groups of patients at various time points.

  7. The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC)

    Time frame: 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.

  8. thrombelastogram (TEG)

    Time frame: 4 days

    The primary outcome measure is the statistical differences in thrombelastogram (TEG) between the two groups of patients at various time points.

  9. Platelet Count (PLT)

    Time frame: 4 days

    The primary outcome measure is the statistical differences in platelet count (PLT) between the two groups of patients at various time points.

  10. The rate of bleeding-related events

    Time frame: 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.

  11. The Milliliters of blood products

    Time frame: 4 days

    The usage of blood products, including red blood cells, platelets, and fresh frozen plasma.

  12. CPC Score

    Time frame: 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.

Other outcomes

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

    Time frame: 4 days

    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.

Sponsors and collaborators

Lead sponsor

Tang Ziren

Other

Registry information

Official study title

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

Acronym: ITTC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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