Fibrinogen therapy for massive blood loss during elective surgery for craniosynostosis repair, a double blinded randomized controlled study
Phase 3
Completed
- Conditions
- massive blood loss in fused bones of the skullmassive blood loss in surgery for premature fusion of cranial sutures1006447710009720
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
- children primary non-syndromic craniosynostosis undergoing elective surgical repair. Patients with Muencke syndrome and patients with Saethe-Chotze syndrome however, are eligible.
- written informed consent
- age older than 5 months and younger than 25 months
Exclusion Criteria
Exclusion criteria
- coagulation disorders
- hypersensitivity against Haemocomplettan P®
- the presence of a craniofacial malformation syndrome
- anemia
- prior thrombosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The purpose is to evaluate the efficacy of fibrinogen therapy at the start of<br /><br>surgery for craniosynostosis repair to reduce the amount of blood product<br /><br>transfusions in ml required. We hypothesize that the blood loss can be<br /><br>significantly reduced by maintaining the level of fibrinogen above 2 g/L. Fewer<br /><br>transfusions will not only reduce the number of blood donors transfused to the<br /><br>patient, but also the potentially acute and long-term side effects and the<br /><br>costs of the transfused blood products.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are related to intra- and postoperative blood loss,<br /><br>operation time, stay on the intensive care unit, total hospital stay, and<br /><br>postoperative complications such as thromboembolic events or wound infections.<br /><br>Data of the thromboelastographic monitoring will be correlated to the two study<br /><br>arms.</p><br>