Prothrombin complex concentrate in liver transplantatio

• Conditions: liver cirhosiscoagulopathybleeding; MedDRA version: 16.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871; MedDRA version: 16.1Level: PTClassification code 10049227Term: Bleeding time abnormalSystem Organ Class: 10022891 - Investigations; MedDRA version: 16.1Level: PTClassification code 10009802Term: CoagulopathySystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 16.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005650-54-BE
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-20
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

->18 years
-Eligible for orthotopic liver transplantation due to end stage liver disease
-Signed informed consent

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 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Split liver transplantation
-Heterotopic liver transplantation
-Scheduled multiorgan transplantation,
-Scheduled living related-donor transplantation
-Documented congenital coagulation disorders
-Documented history or presence of arterial or venous thrombosis
-Treatment with warfarin/coumarin
-Fulminant hepatic failure without previous liver disease
-Documented coronary artery disease
-Documented thrombophilia
- Hypercoagulability as evaluated by thromboelastography

Study & Design

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