Status:
COMPLETED
Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery
Lead Sponsor:
CSL Behring
Conditions:
Surgical Blood Loss
Postoperative Blood Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and...
Eligibility Criteria
Inclusion
- At Screening:
- Undergoing elective open surgical procedures on any part of the aorta requiring cardiopulmonary bypass (CPB), with or without other cardiac surgical procedures (e.g. valve replacement or repair, coronary artery bypass grafting, etc.).
- 18 years of age or older.
- Written informed consent for study participation obtained before undergoing any study specific procedures.
- Intraoperative (at the 1st 5-minute bleeding mass):
- A 5-minute bleeding mass of 60 to 250 g following discontinuation of CPB, administration of protamine, and establishment of surgical hemostasis.
- Minimum core body temperature 35°C, measured according to local practice.
- Activated clotting time ± 25% of baseline levels.
- Blood pH \> 7.3.
Exclusion
- At Screening and/or baseline:
- Undergoing emergency aortic repair surgery.
- Reoperative aortic surgery at the same anatomic site as the original procedure such as replacement of a previously placed aortic graft. Resternotomy and rethoracotomy are permitted.
- Any operation for infection.
- Proof or suspicion of a congenital or acquired coagulation disorder (e.g. Von Willebrand's disease, hemophilia or severe liver disease) or a prothrombotic disorder (e.g. protein C or S deficiency).
- Myocardial infarction (MI), acute coronary syndrome or stroke in the 2 months preceding study surgery.
- Low molecular weight or unfractionated heparin in the 24 hours preceding study surgery.
- Clopidogrel administration within 5 days preceding study surgery or prasugrel administration within 7 days preceding study surgery or ticagrelor administration in the 48 hours preceding study surgery.
- Factor Xa inhibitors within 2 days preceding study surgery.
- IIb/IIIa antagonist administration in the 24 hours preceding study surgery.
- Use of direct thrombin inhibitors: within 3 days preceding study surgery for dabigatran and within 24 hours preceding study surgery for all others.
- An international normalized ratio \> 1.3 immediately preceding the start of surgery.
- Intraoperative (at the 1st 5-minute bleeding mass):
- Use of any systemic hemostatic therapy (such as FFP, platelets, prothrombin complex concentrates) from the beginning of surgery until IMP administration.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01475669
Start Date
January 1 2012
End Date
September 1 2014
Last Update
September 18 2014
Active Locations (35)
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1
Allgemeines Krankenhaus der Stadt Wien - Universitätskliniken
Vienna, Austria, A-1090
2
Fundacao Universitaria de Cardiologia - Instituto de Cardiol
Porto Alegre, Rio Grande do Sul, Brazil, 90620001
3
InCor
São Paulo, São Paulo, Brazil, 05403-000
4
Providence Health-St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6