A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment with two different Doses of Recombinant Factor XIII following Cardiopulmonary Bypass Surgery - ND
- Conditions
- Aquired FXIII deficiency following cardiopulmonary bypass surgery (CABG (coronary atery bypass grafting) or CABG plus single heart valve replacement/repairs or planned replacement/repair of a single heart valve)MedDRA version: 9.1Level: LLTClassification code 10063919Term: Bypass surgery
- Registration Number
- EUCTR2008-006324-62-IT
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 430
1. Informed consent (IC) obtained before any trial-related activities. (Trial related activities are any procedure that would not have been performed during the normal management of the subject). 2. Age: ≥18 - ≤ 80 years 3. Subjects scheduled to undergo cardiac surgery (CS) requiring CPB 4. Planned: CABG or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve 5. Pre-operative transfusion risk score of 2 or 3 (Table 1?1) 6. Peri-operative use of an antifibrinolytic agent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Known or suspected allergy to trial drug(s) or related products 2. Known intolerance to protamine 3. Known or suspected allergy to the used antifibrinolytic agent 4. Previous randomisation and dosing in this trial 5. The receipt of any investigational drug within 30 days prior to surgery 6. Refusal to receive blood or blood product 7. Planned off pump coronary artery bypass (OPCAB) 8. Planned peri-operative use of Desmopressin (DDAVP) 9. Known heparin induced thrombocytopenia (HIT) 10. Known deficiency of protein C, protein S, antithrombin, or homozygous Factor V Leiden 11. Known congenital bleeding disorders 12. Planned surgery including the aortic arch and/or descending aorta 13. Planned surgery including any implantable ventricular assist device 14. Adult congenital heart diseases 15. Current endocarditis 16. Planned deep hypothermic circulatory arrest (< 28 C) 17. Two or more previous cardiac surgery procedures 18. Emergency cardiac surgery procedures i.e. those that are medically required within 24 hours of presenting with acute symptoms 19. Planned CPB priming with red blood cells (RBC)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method