Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00290836|
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : May 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Control of Local Bleeding in Patients Undergoing Prostatectomy.||Drug: Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2004|
|Study Completion Date :||August 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290836
|Roskilde, Denmark, 4000|
|Study Chair:||Nycomed Clinical Trial Operations||Headquaters|