Trial · NCT05523297
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Requiring Additional Hemostatic Intervention | 60 minutes to 24 hours after first dose of IMP | Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII \[rFVIIa\], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP. |
| Secondary | Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | 60 minutes to 24 hours after first dose of IMP | Defined as 'positive' if no additional hemostatic intervention is required and hemoglobin levels decrease by \<30% (after accounting for red cell transfusions) from 60 minutes to 24 hours after initiation of the first dose of IMP. |
| Secondary | Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | 12 and 24 hours after chest closure | |
| Secondary | Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). | 24 hours after surgery start, after the end of CPB and after IMP initiation | Yes or no refers to whether severe to massive bleeding was present. |
| Secondary | Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB | |
| Secondary | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB | |
| Secondary | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | First 24 hours and 7 days after IMP initiation | |
| Secondary | Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation | |
| Secondary | Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation | |
| Secondary | Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups | 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation | |
| Secondary | Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups | 24 hours after start of surgery, after the end of CPB and after IMP initiation | |
| Secondary | Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups | 24 hours after start of surgery, after the end of CPB and after IMP initiation | |
| Secondary | Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups | 24 hours after start of surgery, after the end of CPB and after IMP initiation | |
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in International Normalised Ratio (INR) Before and After Therapy Administration. | Within 30 minutes before to 60 minutes after the initiation of IMP administration. | The international normalized ratio (INR) is a standardized measure of prothrombin time (PT), ensuring consistency in results across different laboratories. The normal range for INR is around 0.8 to 1.2. Higher INR values indicate a slower clotting time and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the INR. INR reduction was considered successful if the magnitude of the reduction was \>1.0 or the post-treatment level dropped below 1.5 (INR \>1.5 indicates that one or more coagulation factor levels are below the 30% critical threshold) |
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Prothrombin Time (PT) | Within 75 minutes before to within 75 minutes after the initiation of IMP administration | The prothrombin time (PT) measures the time it takes for clotting to occur, primarily assessing the extrinsic pathway of the coagulation cascade. Normal PT values range from 9 to 13 seconds. Higher PT values indicate a prolonged clotting time, suggesting potential issues with clotting factors such as fibrinogen, factors V, VII, and X and prothrombin, and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the PT. |
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Activated Partial Thromboplastin Time (aPTT) | Within 75 minutes before to within 75 minutes after the initiation of IMP administration | Activated partial thromboplastin time (aPTT) is a standard laboratory test that measures how long it takes (in seconds) for clotting to occur (in the presence of an activator). It evaluates the intrinsic and common pathways of the coagulation cascade, assessing factors such as VIII, IX, XI, and XII, as well as fibrinogen. Prolonged aPTT may signify deficiencies in these clotting factors and is associated with bleeding. Effective procoagulant therapy can shorten/normalize the aPTT. |
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Fibrinogen Activity | Within 75 minutes before to within 75 minutes after the initiation of IMP administration | |
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM CT | Within 75 minutes before to within 75 minutes after the initiation of IMP administration | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with clotting time (CT) providing a measure (in seconds) of how quickly a clot starts forming. Prolonged EXTEM CT is associated with bleeding. Effective procoagulant therapy can reduce/normalize the EXTEM CT. |
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM MCF | Within 75 minutes before to within 75 minutes after the initiation of IMP administration | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with maximum clot firmness (MCF) providing a measure (in mm) of the strength of the clot. Reduced EXTEM MCF is associated with bleeding. Effective procoagulant therapy can increase/normalize the EXTEM MCF. |
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM FIBTEM MCF | Within 75 minutes before to within 75 minutes after the initiation of IMP administration | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the FIBTEM test evaluates fibrin-based clotting - it is extrinsically activated with tissue factor and additionally incorporates an inhibitor to eliminate the contribution of platelets to clotting. Maximum clot firmness (MCF) in the FIBTEM test provides a measure (in mm) of the strength of the fibrin-based clot. Reduced FIBTEM MCF is associated with bleeding. Effective procoagulant therapy to restore fibrinogen can increase/normalize the FIBTEM MCF. |
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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