TEG based application of fibrinogen in children.
Completed
- Conditions
- blood lossfibrinogendouble-blind trialcraniosynostosis
- Registration Number
- NL-OMON28896
- Lead Sponsor
- Erasmus MCDr. Molewaterplein 603015 GJ Rotterdamthe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 114
Inclusion Criteria
1. Primary non-syndromic craniosynostosis undergoing elective repair from September 2011;
2. Written informed consent;
Exclusion Criteria
1. The presence of congenital bleeding diathesis or congenital prothrombotic risk factors like proteine C or S deficiency or antithrombin deficiency. (Congenital Factor F Leiden and the prothrombin F II mutation are no contraindication for surgery);
2. Known hypersensitivity against Haemocomplettan P®;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perioperative blood loss.
- Secondary Outcome Measures
Name Time Method 1. Duration of the operation time;<br /><br>2. The number of hours of post-operative intensive care admission;<br /><br>3. Duration of total hospital stay;<br /><br>4. Postoperative complications such as thromboembolic events or wound infections;<br /><br>5. The safety of fibrinogen infusion in this patient group;<br /><br>6. Monitoring of coagulation parameters including TEG.