Supportive haemostatic treatment in patients having elective surgery on the heart, the ascending aorta or arch, requiring pulmonary bypass procedure.
Conditions
Interventions
Trade Name: TachoSil
Pharmaceutical Form:
INN or Proposed INN: Human fibrinogen
Concentration unit: mg milligram(s)
Concentration number: 5.5 mg per cm2-
INN or Proposed INN: Human thrombin
Current S
Sponsors
Nycomed Danmark ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed consent given. 2) Negative pregnancy test for females. 3)Use of adequate contraception for females of child-bearing potential. 4) Age - at least 18 years old. 5) Planned elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary procedure. 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
Exclusion criteria: 1) Participation in any other trial with investigational drug or device within 30 days before inclusion in this trial. 2) Participation in a clinical trial concomitantly with the present trial. 3) Patient undergoing emergency operation. 4) History of allergic reactions after application of human fibrinoge, human thrombin and/or collagen of any origin. 5) Suffering from known coagulopathy. 6) Currently participation or previously participation in the trial. 7) Pregnant or breast feeding females. Intra operative: 8) Application of liquid fibrin sealant/glue. 9) Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate efficacy and safety of Tachosil in cardiovascular surgery. ;Secondary Objective: Not applicable;Primary end point(s): Proportion of patients achieving haemostasis after 3 minutes | — |
Countries
Denmark, France, Germany, Italy, Spain
Outcome results
None listed