Efficacy and safety of Haemocomplettan® P in patients experiencing microvascular bleeding while undergoing elective complex cardiac surgery - fib-trial

Athena Care/ Isala Klinieken0 个研究点开始时间: 2010年7月1日最近更新: 2015年2月16日

试验速览

暂无简介。

•- Eighteen years of age or older.
•- Undergoing elective complex cardiac surgery ( CABG and valve(s) or multiple valves or aortic root, aorta ascendens or aortic arch surgery).
•- Understood and willingly given written informed consent (Dutch language) to participate following an explanation of study background, restrictions, and procedures.
•- Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery. clinically relevant microvascular bleeding defined as a 5-minute bleeding mass between 60 and 250 g and intraoperative conditions before infusion of study medication are:
•- Body temperature > 36°C
•- Blood pH > 7.3
•- Hb > 5.3 mmol/L or Ht > 0.25
•- ACT < 130 seconds
•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

•- Positive pregnancy test, pregnancy or lactation.
•- Women of child-bearing age not using a medically approved method of contraception during the study.
•- Undergoing an emergency operation.
•- Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease).
•- Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery.
•- Manifest venous or arterial thrombosis
•- Use of medication:
•- ASA administration in the 3 days preceding surgery.
•- Clopidogrel administration in the 5 days preceding surgery.
•- Tirofiban administration in the 2 days preceding surgery.
•- INR >1.4 if on coumadines.
•- Participation in another clinical study in the 4 weeks preceding this study.
•- Sensitivity to any of the components of study medication.
•- Any indication that the restrictions or procedures of the study may not be
•adhered to (e.g. an uncooperative attitude).
•- Any indication that the study restrictions, procedures, or consequences
•therein have not been considered or understood, such that informed
•consent cannot be convincingly given.
•- Multiple morbidities, with a notably constrained remaining length of life.

发起方

Athena Care/ Isala Klinieken