Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Nycomed |
---|---|
Information provided by: | Nycomed |
ClinicalTrials.gov Identifier: | NCT00290836 |
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.
Condition | Intervention | Phase |
---|---|---|
Control of Local Bleeding in Patients Undergoing Prostatectomy. |
Drug: Human fibrinogen/thrombin and bovine aprotinin (TachoComb H) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 120 |
Study Start Date: | May 2004 |
Study Completion Date: | August 2007 |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?
After prostate resection and primary haemostatic treatment
Exclusion:
At pre-operative screen
Does the patient participate in a clinical trial concomitantly with present trial?
After tumour resection and primary haemostatic treatment
Responsible Party: | Clinical Trial Operations ( Nycomed ) |
Study ID Numbers: | TC-017-AU |
Study First Received: | December 16, 2005 |
Last Updated: | February 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00290836 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Thrombin Hemorrhage Aprotinin |