Status:
COMPLETED
Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
Lead Sponsor:
University Children's Hospital, Zurich
Conditions:
Blood Coagulation Disorders
Hemorrhage
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative...
Eligibility Criteria
Inclusion
- Males and Females
- Age 6 months to 17 years
- Scheduled for elective scoliosis surgery or major craniofacial surgery
- Written informed consent has been obtained
- Intraoperative hypofibrinogenemia according to definition of treatment groups
Exclusion
- Preexisting congenital or acquired coagulation disorder
- Medical history of estimated increased bleeding tendency
- Ongoing coagulation therapy
- Clinical signs or diagnosis of acute thromboembolism
- Intolerance of study drug
- Participation at another clinical trial
- Pregnant or lactating women
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01487837
Start Date
January 1 2012
End Date
October 1 2014
Last Update
October 27 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zurich University Children's Hospital
Zurich, Switzerland, 8032