blood loss fibrinogen double-blind trial craniosynostosis
Conditions
Interventions
The intervention being studied is the application of 100 mg/kg BW of fibrinogen concentrate (=50 ml) given IV in a dose of 50 mg/kg body weight (BW) immediately at the start of surgery, followed by 50
Sponsors
Erasmus MC
Dr. Molewaterplein 60
3015 GJ Rotterdam
the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primary non-syndromic craniosynostosis undergoing elective repair from September 2011; 2. Written informed consent; 3. Age older than 5 months and younger than 15 months.
Exclusion criteria
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®; 3. Known coagulopathy; 4. Presence of a craniofacial malformation syndrome; 5. Active infectious disease; 6. Patients with anemia or thrombocytopenia before the surgical intervention; 7. Patients with prior thrombo-embolic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative blood loss. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of the operation time; 2. The number of hours of post-operative intensive care admission; 3. Duration of total hospital stay; 4. Postoperative complications such as thromboembolic events or wound infections; 5. The safety of fibrinogen infusion in this patient group; 6. Monitoring of coagulation parameters including TEG. | — |
Contacts
Public ContactCH Ommen, van
Outcome results
None listed