Prothrombin Complex Concentrate in the reduction of blood loss during orthotoppic liver transplantation.
Recruiting
- Conditions
- cirrhosisbleedinghemorrhagecomplicationshemostasiscoagulation
- Registration Number
- NL-OMON28249
- Lead Sponsor
- Sanquin Plasma Products
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
1. 18y;
2. Cirrhosis, scored as Child-Turcotte- Pugh class B or C or > 13 or as model of end-stage liver disease (MELD) score of > 20;
Exclusion Criteria
1. Previous liver transplantation;
2. Split liver transplantation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transfusion requirements per-operative To study the hemostatic efficacy of preoperative PCC administration in patients with cirrhosis undergoing liver transplantation. The hemostatic efficacy will be primarily monitored by recording the need for RBC transfusion.
- Secondary Outcome Measures
Name Time Method To study the hemostatic safety of preoperative PCC administration in patients with cirrhosis undergoing liver transplantation. The hemostatic safety will be monitored by adverse event surveillance and laboratory measurements, with a special focus on thrombogenicity.