Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)
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.
Control of Local Bleeding in Patients Undergoing Prostatectomy.
Drug: Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Efficacy: Is the percentage of patients/treatment group in which efficient intra-operative haemostasis is achieved within 10 minutes after applying test treatment according to randomisation after primary surgical haemostasis.
- Haemoglobin concentration of drainage fluid on day 1 after surgery.
- Haemotocrit concentration of drainage fluid on day 1 after surgery.
- Volume of drainage fluid on day 1 after surgery.
- Incidence of post-operative haematoma at removal site at day 2 after surgery (sonography).
- Incidence of tumour positive resection margin proven by histology (discharge).
- Reporting of occurrence of urinary incontinence (discharge, 3 months +/- 10 days (and optional 12 months +/- 30 days) after surgery.
|Study Start Date:||May 2004|
|Study Completion Date:||August 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290836
|Roskilde, Denmark, 4000|
|Study Chair:||Nycomed Clinical Trial Operations||Headquaters|