Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)

Nycomed

Status and phase: Completed; Phase 4

Conditions: Control of Local Bleeding in Patients Undergoing Prostatectomy.

Treatments: Drug: Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00290836

TC-017-AU

Details and patient eligibility

About

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 include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin and haematocrit concentration of drainage fluid.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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)?

Exclusion:

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 randomisation?

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)