Trial · NCT00708435
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed | At 1 and 4 hours after the end of infusion | The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) | 30 minutes after end of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding | At 3 and 6 hours after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex | Before infusion and up to 3 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | (IU/dL)/(IU/kg body weight) | MEAN |
| SECONDARY | Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | From preinfusion until 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of normal | MEAN |
| SECONDARY | Percentage of Participants With INR Correction at Various Times After the Start of Infusion | From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion. | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With INR Correction at Various Times After Randomization | From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization. | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Transfusion of Red Blood Cells | From the start of infusion until 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | Units of PRBCs | MEAN |
| SECONDARY | Use of Other Blood Products and Hemostatic Agents | From the start of infusion until 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | Units of blood products | MEAN |
| SECONDARY | 45-Day All-cause Mortality | Until Day 45 | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | participants | NUMBER |
| SECONDARY | Overall Treatment-emergent Adverse Events (TEAEs) | From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs. | The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. | participants | NUMBER |
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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