A study to assess the efficacy of Beriplex P/N compared with plasma for quick reversal of anticoagulant medicines in patients who require an urgent surgery

Active, not recruiting

• Conditions: Perioperative prophylaxis for emergency surgery in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S; MedDRA version: 14.1Level: PTClassification code 10065667Term: Haemorrhage prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10009789Term: Coagulation factors decreasedSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2007-007862-39-BG
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-13
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

. Male and female subjects 18 years or more,
. Subjects currently on oral VKA therapy,
. An urgent surgical procedure is required within 24 hours of the start of IMP,
. Due to the nature of the procedure, withdrawal of oral VKA therapy and infusion of plasma are also indicated to reverse the VKA effect,
. INR . 2 within 3 hours before start of IMP,
. Informed consent has been obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93

Exclusion Criteria

•Subjects requiring urgent surgical procedures where according to the surgeon's clinical judgment, an accurate estimate of blood loss is not possible (e.g., ruptured aneurysm)
•Subjects in whom lowering INR within normal range may present an unacceptable risk for a thromboembolic complication where the INR goal is to lower but not normalize the INR because of risk of a procedure-associated stroke
•Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control or resolve an acute bleeding complication and/or control the acute bleeding event
•History of thromboembolic event, myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified