Intervention pilot with fibrinogen concentrate and the combination of fibrinogen concentrate with FFP in patients with massive post/peri-operative bleeding problems
- Conditions
- general surgery patients, heart valve replacement, peri/post operative bleeding problemsalgemene chirurgie patiënten, hartklep vervanging, peri/post operatieve bloedingsproblemen
- Registration Number
- NL-OMON24904
- Lead Sponsor
- dr. JWM. HeemskerkP.I. CARIM
- Brief Summary
Main resource:<br> Mittermayr M et al. Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery:the role of fibrinogen administration. Anesth Analg. 2007; 105
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. General surgery patients with massive peri-operative bloodloss, with an indication of receiving 4 units of FFP according to current guidelines.
2. Cardiothoracic surgery patients after heart valve replacement who met the criteria of increased bloodloss and indication for DDAVP.
Exclusion Criteria
1. No other therapeutical anti-thrombotica are given, other than platelet-aggregation inhibitors
2. Patients with active HIV-infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stop of bleeding after the therapy. The clinical situtation after the treatment will be compared with conventional coagulation tests (aPTT, PT, fibrinogen level).
- Secondary Outcome Measures
Name Time Method Thrombin generation and thromboelastography measurements, measured with the CAT en TEG method.