TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN) - Full Text View

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00241163

Purpose

The overall objective is to compare efficacy and safety of TachoComb S and standard surgical treatment for the control of local bleeding in patients undergoing surgical resection of renal tumours. Specific objectives include the comparison between test treatments of intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma formation, and surgeon's rating of usefulness of test treatment.

Condition	Intervention	Phase
Surgical Resection of Superficial Renal Tumour	Procedure: Fibrinogen (human) + thrombin (human) (TachoSil)	Phase III

MedlinePlus related topics: Cancer Kidney Cancer Surgery

Drug Information available for: TachoComb TachoSil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Nycomed:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Secondary efficacy endpoints are: 1) proportion of patients with haemostasis 10 minutes after start of test treatment; 2) haematoma formation on day 2 after surgery (sonography).
Adverse events will be recorded from screening until follow-up.

Estimated Enrollment:

170

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241163

Locations

Denmark
Nycomed
Roskilde, Denmark, 4000

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Please refer to this study by ClinicalTrials.gov identifier NCT00241163, Nycomed

clinicaltrials@nycomed.com

More Information

No publications provided

Responsible Party:	Clinical Trial Operations ( Nycomed )
Study ID Numbers:	TC-015-IN
Study First Received:	October 16, 2005
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00241163 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Thrombin
Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases

Kidney Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009