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

Active, not recruiting

• Conditions: Elective complex cardiac surgery is associated with excessive blood loss due to coagulopathy. Fibrinogen concentrate has been shown to reverse dilutional coagulopathy. In this double blinded, placebo-controlled, randomized trial we will investigate whether fibrinogen concentrate reduced blood loss and transfusion of blood products in patients experiencing excessive coagulopathic bleeding during elective complex cardiac surgery.; MedDRA version: 12.1Level: LLTClassification code 10009802Term: Coagulopathy; MedDRA version: 12.1Level: LLTClassification code 10000531Term: Acquired afibrinogenaemia; MedDRA version: 12.1Level: LLTClassification code 10005517Term: Blood fibrinogen; MedDRA version: 12.1Level: LLTClassification code 10011976Term: Decreased plasma fibrinogen

• Registration Number: EUCTR2009-018086-12-NL
• Lead Sponsor: Athena Care/ Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-01
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

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

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Perioperative blood loss in ml measured between infusion of study medication and closure of chest.<br>;Main Objective: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss in patients experiencing clinically relevant microvascular bleeding during elective complex cardiac surgery.;Secondary Objective: To determine whether fibrinogen concentrate infusion reduces transfusion of allogenic blood products in patients experiencing clinically relevant microvascular bleeding during elective complex cardiac surgery and to determine whether its use is safe and well-tolerated.