- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440401
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
A Randomised, Open Label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety of TachoSil® Versus Standard Haemostatic Treatment in Cardiovascular Surgery
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Roskilde, Denmark, 4000
- Nycomed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
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?
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: TachoSil®
|
|
ACTIVE_COMPARATOR: Standard Treatment
Standard Treatment of haemorrhage in cardiovascular surgery
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Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Achieving Haemostasis at 3 Minutes
Time Frame: 3 minutes
|
Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
|
3 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Achieving Haemostasis at 6 Minutes.
Time Frame: 6 minutes
|
Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
|
6 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC-023-IM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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