The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients
NCT Number: NCT06543849
Acronym: ITTC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Targeted Temperature Management|Cardiac Arrest|Thrombin Function|Treatment Duration
Interventions: PROCEDURE: Target Temperature Management Treatment
Sponsor: Tang Ziren
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-12-31

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.

Primary Outcome Measures: 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: 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|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|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|The Milliliters of blood products, The usage of blood products, including red blood cells, platelets, and fresh frozen plasma., 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: 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