Status:
COMPLETED
Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)
Lead Sponsor:
Nycomed
Conditions:
Control of Local Bleeding in Patients Undergoing Prostatectomy.
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. Specific objectives in...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- has the subject given informed consent according to local requirements before any trial related activies? A trial related activity is any procedure that would not have been performed during the routine management of the subject.
- Is the subject 18 years of age or above ?
- Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?
- After prostate resection and primary haemostatic treatment
- is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?
- Exclusion:
- At pre-operative screen
- Is there anamnestic or laboratory evidence of coagulation disorders including haemophilia A or B and von Willebrand disease ?
- Has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin?
- Is the patient undergoing an emergency operation?
- Did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial?
- Does the patient participate in a clinical trial concomitantly with present trial?
- After tumour resection and primary haemostatic treatment
- Has any serious surgical complication occurred?
- Has any fibrin glue haemostatic (including any type of TachoComb) been used before randomisation?
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00290836
Start Date
May 1 2004
End Date
August 1 2007
Last Update
May 7 2012
Active Locations (1)
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1
Nycomed
Roskilde, Denmark, 4000