Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00708435 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
A Phase 3 study of Blood Coagulation Disorders and Acute Major Bleeding, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
- 20
- Study locations
NCT00708435: Completed Phase 3 study of Blood Coagulation Disorders and Acute Major Bleeding, sponsored by CSL Behring.
NCT00708435 is a Phase 3 study of Blood Coagulation Disorders and Acute Major Bleeding that has completed, run by CSL Behring. The registered enrollment target is 216 participants, roughly in line with the 227-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00708435, a Phase 3 study of Blood Coagulation Disorders and Acute Major Bleeding, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.
Primary Outcome
Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none".
Conditions Studied
Interventions
- BIOLOGICAL Fresh frozen plasma
- BIOLOGICAL Beriplex® P/N (Kcentra)
Study Locations (20)
California
- Study Site - Los Angeles
- Study Site - San Franciso
Florida
- Study Site - Orlando
- Study Site - Tampa
Illinois
- Study Site - Chicago
- Study Site - Oak Park
Maryland
- Study Site - Baltimore
- Study Site - Baltimore
Massachusetts
- Study Site - Boston
- Study Site - Worchester
Michigan
- Study Site - Ann Arbor
- Study Site - Royal Oak
Minnesota
- Study Site - Duluth
- Study Site - Minneapolis
Alabama
- Study Site - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00708435 record still lists
NCT00708435 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 227-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target.
The record links to 2 conditions, with Blood Coagulation Disorders appearing as the primary indexed condition, and to 2 interventions - of which Fresh frozen plasma is the first listed.
NCT00708435 names 20 study sites across 13 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00708435 about?
NCT00708435 is a clinical study titled "Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy". The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute...
What is the current status of trial NCT00708435?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2008-06. Estimated completion is 2010-11.
What conditions does trial NCT00708435 study?
This clinical trial studies the following conditions: Blood Coagulation Disorders, Acute Major Bleeding.
What interventions are being tested in trial NCT00708435?
The interventions under investigation include: Fresh frozen plasma (BIOLOGICAL), Beriplex® P/N (Kcentra) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00708435?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00708435 being conducted?
This trial has 20 study locations across Alabama, California, Delaware, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Blood Coagulation Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
RECRUITING
-
Thrombin Generation in Neonates
COMPLETED
-
CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study
COMPLETED
-
A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,
COMPLETED · Phase 2
-
Study of Megakaryocytes From Patients With Abnormal Platelet Vesicles
COMPLETED
-
Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02609685 · 216 participants · NA
Active Surveillance of Papillary Thyroid Microcarcinoma
- NCT04994873 · 216 participants · NA
Skills to Enhance Positivity in Suicidal Youth
- NCT05264779 · 216 participants · NA
The Periviable GOALS Decision Support Tool
- NCT05434130 · 216 participants · Phase 2
Modulating Exercise Dosage to Improve Concussion Recovery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia