An Open, Randomised, Prospective, Multicentre, Parallel-group Trial to Compare Efficacy and Safety of TachoComb S Versus Standard Surgical Treatment in Patients Undergoing Surgical Resection of Superficial Renal Tumour.
18 Years
40 Years
Both
Surgical Resection of Superficial Renal Tumour
Trial Information
An Open, Randomised, Prospective, Multicentre, Parallel-group Trial to Compare Efficacy and Safety of TachoComb S Versus Standard Surgical Treatment in Patients Undergoing Surgical Resection of Superficial Renal Tumour.
Inclusion Criteria:
Patients of or above 18 years of age scheduled for resection of superficial tumour on the
kidney and scheduled for open surgery. After the tumour resection the wound should be
suitable for the treatments in the study, and the integrity of the urinary tract should be
maintained.
Exclusion criteria:
Patients undergoing an emergency operation, or with more than one tumour will be excluded.
Patients with a clinically abnormal value of prothrombin time or activated partial
thromboplastin time, anamnetic evidence of coagulation disorders and a history of allergic
reactions after application of human fibrinogen, human thrombin and/or collagen will be
excluded. In case the tumour was resected by use of a laser scalpel, infrared coagulator
or argon beamer and if any fibrin glue haemostatic was used before randomisation the
patient will be excluded from the trial. Furthermore, patients will be excluded if
extensive resection/extirpation of the kidney become necessary or in case of serious
surgical complication occurring during the operation.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.
Principal Investigator
Please refer to this study by ClinicalTrials.gov identifier NCT00241163, Nycomed
Investigator Role:
Study Chair
Investigator Affiliation:
Nycomed: A Takeda Company
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
TC-015-IN
NCT ID:
NCT00241163
Start Date:
Completion Date:
Related Keywords:
- Surgical Resection of Superficial Renal Tumour
- Kidney Neoplasms
Name | Location |
|---|
