Fibrinogen therapy for massive blood loss in childre

Phase 1

• Conditions: massive blood loss in surgery for premature fusion of cranial sutures, massive blood loss in fused bones of the skull; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 17.1Level: LLTClassification code 10005645Term: Blood loss of (NOS)System Organ Class: 100000004866

• Registration Number: EUCTR2011-002287-24-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- primary non-syndromic craniosynostosis undergoing elective repair
- written informed consent
- age older than 5 months and younger than 25 months
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- the presence of congenital bleeding diathesis or congenital prothrombotic risk factors like protein C or S deficiency or antithrombin deficiency. (Congenital Factor F Leiden and the prothrombin F II mutation are no contraindication for surgery).
- known hypersensitivity against Haemocomplettan P®
- known coagulopathy
- presence of a craniofacial malformation syndrome.
- active infectious disease
- patients with anemia or thrombocytopenia before the surgical intervention
- patients with prior thrombo-embolic disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified