Cardiac Arrest, Targeted Temperature Management, Thrombin Function, Treatment Duration
Conditions
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.
Interventions
Target Temperature Management Treatment
Sponsors
Tang Ziren
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombin Time (TT) | 4 days | The primary outcome measure is the statistical differences in thrombin time (TT) between the two groups of patients at various time points. |
| Prothrombin Time (PT) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The concentration of fibrinogen (FBG) | 4 days | The primary outcome measure is the statistical differences in fibrinogen (FBG) between the two groups of patients at various time points. |
| The concentration of thrombin-antithrombin complex (TAT) | 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. |
| The concentration of thrombomodulin (TM) | 4 days | The primary outcome measure is the statistical differences in thrombomodulin (TM) between the two groups of patients at various time points. |
| The concentration of tissue-type plasminogen activator inhibitor complex (T-PAIC) | 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. |
| Platelet Count (PLT) | 4 days | The primary outcome measure is the statistical differences in platelet count (PLT) between the two groups of patients at various time points. |
| The rate of bleeding-related events | 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. |
| The Milliliters of blood products | 4 days | The usage of blood products, including red blood cells, platelets, and fresh frozen plasma. |
| CPC Score | 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. |
| thrombelastogram (TEG) | 4 days | The primary outcome measure is the statistical differences in thrombelastogram (TEG) between the two groups of patients at various time points. |
| The concentration of D-dimer (D-D) | 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. |
| International Normalized Ratio (INR) | 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. |
| The concentration of plasmin-α2-plasmin inhibitor complex (PIC) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The percentage of serious adverse events during the 4-day treatment period | 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. |
Countries
China
Outcome results
None listed