Targeted Temperature ManagementITTCNCT06543849
The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients
A study testing Target Temperature Management Treatment in people with Targeted Temperature Management and Cardiac Arrest, run by Tang Ziren at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Targeted Temperature Management, Cardiac Arrest, Thrombin Function
- What is being tested?
- Target Temperature Management Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
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
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.
- Being tested
- Target Temperature Management Treatment
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target Temperature Management TreatmentProcedure or surgery
Target Temperature Management Treatment
| Study group | Role | What they receive |
|---|---|---|
| 24-hour treatment | Sham comparator | Not described Receives: Procedure: Target Temperature Management Treatment |
| 72-hour treatment | Active comparator | Not described Receives: Procedure: Target Temperature Management Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 days
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 days
thrombelastogram (TEG)
The primary outcome measure is the statistical differences in thrombelastogram (TEG) between the two groups of patients at various time points.
Measured: 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.
Measured: 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.
Measured: 4 days
The Milliliters of blood products
The usage of blood products, including red blood cells, platelets, and fresh frozen plasma.
Measured: 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.
Measured: 28 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Targeted Temperature ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang Ziren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tang Ziren, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543849
- Sponsor's protocol ID
- 2023-1-26-5
- Acronym
- ITTC
- Status last verified
- Apr 2025
- First submitted
- 1 Aug 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06543849
- Acronym / sponsor ID
- ITTC / 2023-1-26-5
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tang ZirenUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24-hour treatment | Sham comparator | Procedure: Target Temperature Management Treatment |
| 72-hour treatment | Active comparator | Procedure: Target Temperature Management Treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target Temperature Management TreatmentTarget Temperature Management Treatment | Procedure or surgery | 24-hour treatment, 72-hour treatment |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
The concentration of D-dimer (D-D)
Time frame: 4 days
International Normalized Ratio (INR)
Time frame: 4 days
The concentration of plasmin-α2-plasmin inhibitor complex (PIC)
Time frame: 4 days
The concentration of fibrinogen (FBG)
Time frame: 4 days
The concentration of thrombin-antithrombin complex (TAT)
Time frame: 4 days
The concentration of thrombomodulin (TM)
Time frame: 4 days
The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC)
Time frame: 4 days
thrombelastogram (TEG)
Time frame: 4 days
Platelet Count (PLT)
Time frame: 4 days
The rate of bleeding-related events
Time frame: 4 days
The Milliliters of blood products
Time frame: 4 days
CPC Score
Time frame: 28 days and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target Temperature Management Treatment in people with Targeted Temperature Management and Cardiac Arrest, run by Tang Ziren at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prothrombin Time (PT) (time frame: 4 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.