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Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
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Trial · NCT00708435

Results by group86

Each measurement the trial posted, group by group, in the words and numbers it posted.

1 to 20 of 86

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OutcomeGroupCategoryValueSpreadUnits
Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major BleedBeriplex® P/N72.495% Confidence Interval 63.6 to 81.3percentage of participants
Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major BleedFresh Frozen Plasma65.495% Confidence Interval 56.2 to 74.5percentage of participants
Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)Beriplex® P/N62.295% Confidence Interval 52.6 to 71.8percentage of participants
Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)Fresh Frozen Plasma9.695% Confidence Interval 3.9 to 15.3percentage of participants
Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal BleedingBeriplex® P/N73.595% Confidence Interval 64.7 to 82.2percentage of participants
Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal BleedingFresh Frozen Plasma67.395% Confidence Interval 58.3 to 76.3percentage of participants
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for BeriplexBeriplex® P/NFactor II2.00Standard Deviation 0.879(IU/dL)/(IU/kg body weight)
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for BeriplexBeriplex® P/NFactor VII2.15Standard Deviation 2.958(IU/dL)/(IU/kg body weight)
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for BeriplexBeriplex® P/NFactor IX1.29Standard Deviation 0.711(IU/dL)/(IU/kg body weight)
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for BeriplexBeriplex® P/NFactor X1.96Standard Deviation 0.871(IU/dL)/(IU/kg body weight)
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for BeriplexBeriplex® P/NProtein C2.04Standard Deviation 0.958(IU/dL)/(IU/kg body weight)
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for BeriplexBeriplex® P/NProtein S2.17Standard Deviation 1.661(IU/dL)/(IU/kg body weight)
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor II, pre-infusion (n = 98; 103)20.1Standard Deviation 14.56percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor II, pre-infusion (n = 98; 103)22.3Standard Deviation 22.39percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor II, 0.5 h after infusion start (n = 88; 90)87.5Standard Deviation 44.48percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor II, 0.5 h after infusion start (n = 88; 90)31.9Standard Deviation 22.55percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor II, 24 h after infusion start (n = 92; 99)77.1Standard Deviation 22.06percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor II, 24 h after infusion start (n = 92; 99)58.1Standard Deviation 19.55percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SBeriplex® P/NFactor VII, pre-infusion (n = 98; 103)25.9Standard Deviation 35.01percentage of normal
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein SFresh Frozen PlasmaFactor VII, pre-infusion (n = 98; 103)23.5Standard Deviation 23.45percentage of normal

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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  • 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
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  • 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)

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