Status:
COMPLETED
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
Lead Sponsor:
Nycomed
Conditions:
Haemorrhage
Haemostasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
Eligibility Criteria
Inclusion
- All inclusion criteria must be answered "yes" for a subject to participate in the trial.
- At Screening:
- Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
- For female subjects of childbearing potential: Is the pregnancy test at screening negative?
- Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
- Is the subject ≥ 18 years of age?
- Is the following planned: An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure?
- Intra operative (after primary haemostatic treatment):
- Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?
- Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).
- Is it possible to compress the randomised treatment (TachoSil® or control fleece material) for 3 minutes?
Exclusion
- All exclusion criteria must be answered "no" for a subject to participate in the trial.
- At Screening:
- Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?
- Does the subject participate in a clinical trial concomitantly with the present trial?
- Is the subject undergoing an emergency operation?
- Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- Is the subject suffering from known coagulopathy?
- Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?
- Is the female subject pregnant or breast feeding?
- Intra operative (after primary haemostatic treatment):
- Has liquid fibrin sealant/glue or TachoSil® been applied?
- Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00440401
Start Date
February 1 2007
End Date
November 1 2007
Last Update
May 8 2012
Active Locations (1)
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1
Nycomed
Roskilde, Denmark, 4000