Trial · NCT07897006
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in SOFA score from baseline to Day 14 | From baseline (before the first dose) through Day 14 | The Sequential Organ Failure Assessment (SOFA) score is a measure of organ dysfunction (range 0-24, higher scores indicate more severe dysfunction). The primary endpoint is the improvement value defined as the baseline SOFA score minus the Day 14 SOFA score, compared among the three groups. SOFA scores are assessed at baseline (before the first dose) and on Day 14. Component-level scores are reported separately as a pre-specified supportive outcome. |
| Secondary | Change in ISTH-DIC score from baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | The International Society on Thrombosis and Haemostasis (ISTH) overt disseminated intravascular coagulation score, calculated at each assessment time point from platelet count, prothrombin time, fibrinogen, and D-dimer (or fibrin degradation products); a total score of 5 or more indicates overt DIC. Analyzed as change from baseline. |
| Secondary | All-cause mortality at 28 days | 28 days after randomization | All-cause mortality is defined as death from any cause within 28 days after randomization, counted for all randomized participants regardless of causality assessment. Vital status at Day 28 is collected for all participants. |
| Secondary | ICU length of stay and total hospital length of stay | From randomization to hospital discharge or through study completion, an average of approximately 22 days | Duration of intensive care unit stay and total hospital stay, measured in days from randomization to ICU discharge and to hospital discharge or death, respectively, for all randomized participants. |
| Secondary | Change in SOFA Component Scores for Hepatic, Renal, Respiratory, and Cardiovascular Function from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | The total SOFA score (0-24) is the primary endpoint of this study; this outcome reports the pre-specified component-level analysis supporting it. The SOFA score grades six organ systems, each 0-4 points. This outcome reports the hepatic (serum total bilirubin), renal (serum creatinine or receipt of renal replacement therapy), respiratory (PaO2/FiO2 ratio), and cardiovascular (mean arterial pressure and vasopressor use) components, each scored 0-4 per the SOFA definitions in the Sepsis-3 criteria. Change is calculated as baseline minus the Day N score, consistent with the primary endpoint direction, so positive values indicate improvement; components are reported individually in points. |
| Secondary | Change in Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Prothrombin time (PT, seconds) and activated partial thromboplastin time (APTT, seconds) measured from venous blood samples collected at each protocol-specified time point. |
| Secondary | Change in International Normalized Ratio (INR) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | The international normalized ratio (INR), calculated from the prothrombin time and the international sensitivity index (ISI) of the thromboplastin reagent used, reported as a dimensionless ratio; analyzed as change from baseline. |
| Secondary | Change in Fibrinogen (FG) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Plasma fibrinogen concentration measured in venous blood samples collected at each protocol-specified time point, reported in g/L; analyzed as change from baseline. Fibrinogen is both an acute-phase reactant and the substrate of fibrin formation. |
| Secondary | Change in D-dimer from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Plasma D-dimer, a marker of endogenous fibrin formation and degradation, measured in venous blood samples collected at each protocol-specified time point, reported in mg/L; analyzed as change from baseline. Elevated D-dimer at screening is an eligibility criterion of this study. |
| Secondary | Change in Platelet Count from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Platelet count measured in venous blood samples collected at each protocol-specified time point, reported as 10\^9/L; analyzed as change from baseline. Platelet count is also a component of the ISTH-DIC score. |
| Secondary | Change in Antithrombin III (AT III), Protein C Activity, and Coagulation Factor Activities (FV, FVII, FVIII) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Antithrombin III activity, protein C activity, and coagulation factor V, VII, and VIII activities measured in citrated plasma at each protocol-specified time point, all reported as percent activity; each analyte analyzed as change from baseline. |
| Secondary | Change in PAI-1, T-PAIC, and t-PA from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Plasma plasminogen activator inhibitor-1 (PAI-1), tissue plasminogen activator-inhibitor complex (T-PAIC), and tissue-type plasminogen activator (t-PA) measured in venous blood samples at baseline and on Day 14, all reported in ng/mL; each analyte analyzed as change from baseline. Together these characterize fibrinolytic activity and its inhibition. |
| Secondary | Change in Plasmin-alpha2 Plasmin Inhibitor Complex (PIC) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Plasma plasmin-alpha2 plasmin inhibitor complex (PIC), a marker of endogenous fibrinolysis, measured in venous blood samples at baseline and on Day 14, reported in ug/L; analyzed as change from baseline. |
| Secondary | Change in Thromboelastography (TEG) Reaction Time (R) and Kinetics Time (K) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Thromboelastography (TEG) R time, reflecting the rate of initial fibrin formation, and K time, reflecting the kinetics of clot strengthening, performed on citrated whole blood at baseline and on Day 14, both reported in minutes; each parameter analyzed as change from baseline. |
| Secondary | Change in Thromboelastography (TEG) Alpha Angle from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Thromboelastography (TEG) alpha angle, reflecting the speed of fibrin build-up and thrombin activity, performed on citrated whole blood at baseline and on Day 14, reported in degrees; analyzed as change from baseline. |
| Secondary | Change in Thromboelastography (TEG) Maximum Amplitude (MA) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Thromboelastography (TEG) maximum amplitude (MA), reflecting the strength of the platelet-fibrin clot and overall platelet function, performed on citrated whole blood at baseline and on Day 14, reported in millimeters; analyzed as change from baseline. |
| Secondary | Change in Thrombomodulin (TM), Thrombin-Antithrombin Complex (TAT), and ICAM-1 from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Plasma thrombomodulin (TM), thrombin-antithrombin complex (TAT), and intercellular adhesion molecule-1 (ICAM-1) measured in venous blood samples at baseline and on Day 14, all reported in ng/mL; each analyte analyzed as change from baseline. TAT reflects in vivo thrombin generation, while TM and ICAM-1 reflect endothelial injury and activation. |
| Secondary | Change in von Willebrand Factor (VWF) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Plasma von Willebrand factor (VWF), an established marker of endothelial activation that mediates platelet adhesion, measured in venous blood samples at baseline and on Day 14, reported in IU/dL; analyzed as change from baseline. |
| Secondary | Change in Endothelin-1 (ET-1) and Angiopoietin-2 (ANG-2) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | Plasma endothelin-1 (ET-1) and angiopoietin-2 (ANG-2) measured in venous blood samples at baseline and on Day 14, both reported in pg/mL; each analyte analyzed as change from baseline. Both markers reflect endothelial dysfunction and vascular permeability. |
| Secondary | Change in Platelet Aggregation Rate and Platelet Adhesion Rate from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0 and 14 | ADP-induced and collagen-induced platelet aggregation rates and the platelet adhesion rate, measured in blood samples at baseline and on Day 14, all reported as percentages; each measure analyzed as change from baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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