Clinical Trials Logo
  1. Home
  2. Acute Major Bleeding
  3. NCT00708435

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

Blood Coagulation Disorders Clinical Trial

Official title:
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Coumarin Derivatives in Subjects With Acute Major Bleeding

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00708435
Study type Interventional
Source CSL Behring
Contact
Status Completed
Phase Phase 3
Start date June 2008
Completion date November 2010
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02239991 - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant N/A
Completed NCT01435304 - The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass N/A
Completed NCT00969319 - Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America N/A
Completed NCT00091494 - Socioeconomic Patterning of Inflammation and Hemostasis - Ancillary to MESA N/A
Completed NCT00005481 - Epidemiology of Impaired Coagulant Balance in Diabetes N/A
Recruiting NCT02379104 - ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals N/A
Withdrawn NCT02774317 - Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months Phase 4
Recruiting NCT01930916 - Accuracy of a Portable International Normalized Ratio Monitor in Elderly Patients N/A
Completed NCT00168090 - Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD) Phase 4
Completed NCT01787552 - A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF Phase 1/Phase 2
Not yet recruiting NCT02782338 - The Effect of Voltaren-ophtha 0.1% Eye Drops on INR Levels (International Normalized Ratio) in Patients Taking Warfarin N/A
Unknown status NCT01349712 - Study to Test the Accuracy of a Prototype Handheld PT/INR Device N/A
Completed NCT01143909 - Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients N/A
Recruiting NCT04762550 - Thrombin Generation in Liver Transplant Surgery
Withdrawn NCT01221389 - Study Using Plasma for Patients Requiring Emergency Surgery Phase 4
Withdrawn NCT00233246 - Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive Procedures Phase 3
Recruiting NCT03884725 - Fibrinogen Concentrate In Children Cardiac Surgery 2 Phase 4
Completed NCT00086476 - Study of Megakaryocytes From Patients With Abnormal Platelet Vesicles N/A
Completed NCT00516126 - Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery Phase 4
Recruiting NCT00214656 - "Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery Phase 3