An Open, Randomised, Prospective, Single-centre Phase IV Trial to Assess Efficacy and Safety of TachoComb H Versus Standard Surgical Treatment (i.e. Suture) in Patients Undergoing Prostatectomy
1. 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.
2. Is the subject 18 years of age or above ?
3. Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?
After prostate resection and primary haemostatic treatment
4. 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)?
At pre-operative screen
1. Is there anamnestic or laboratory evidence of coagulation disorders including
haemophilia A or B and von Willebrand disease ?
2. Has the patient a history of allergic reactions after application of human
fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin?
3. Is the patient undergoing an emergency operation?
4. Did the patient participate in a clinical trial less than 30 days prior to inclusion
in present trial?
5. Does the patient participate in a clinical trial concomitantly with present trial?
After tumour resection and primary haemostatic treatment
6. Has any serious surgical complication occurred?
7. Has any fibrin glue haemostatic (including any type of TachoComb) been used before