Trial · NCT05523297
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Requiring Additional Hemostatic Intervention | 60 minutes to 24 hours after first dose of IMP | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | Data were not available for 2 patients in the FP group due to missing hemoglobin values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | 12 and 24 hours after chest closure | Milliliters (mL) | MEAN | |
| 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 | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | total ABPs | MEAN | |
| 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 | total non-IMP ABPs | MEAN | |
| 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 | Total non-IMP ABPs | MEAN | |
| 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 | ABPs | MEAN | |
| 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 | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | participants | NUMBER | |
| 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 | participants | NUMBER | |
| 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 | Participants | COUNT_OF_PARTICIPANTS | |
| 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 analysis of absolute change included all patients who had INR data available at both pre- and post-IMP time points. | international normalised ratio (INR) | MEAN |
| 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 | seconds | MEAN | |
| 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 | seconds | MEAN | |
| 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 | grams per liter (g/L) | MEAN | |
| 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 | Few data were available as ROTEM measurements were not mandated by the study protocol. | seconds | MEAN |
| 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 | Few data were available as ROTEM measurements were not mandated by the study protocol. | Millimeters (mm) | MEAN |
| 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 | Few data were available as ROTEM measurements were not mandated by the study protocol. | Millimeters (mm) | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05523297/outcomes