Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU) - Full Text View

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00290836

Purpose

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

Drug Information available for: Aprotinin TachoComb

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, Single-Centre Phase IV Trial to Assess Efficacy and Safety of TachoComb H Versus Standard Surgical Treatment (i.e. Suture) in Patients Undergoing Prostatectomy

Further study details as provided by Nycomed:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Efficacy:
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.

Estimated Enrollment:	120
Study Start Date:	May 2004
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

has the subject given informed consent according to local requirements before any trial related activies? A trial related activity is any procedure that would not have been performed during the routine management of the subject.
Is the subject 18 years of age or above ?
Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?

After prostate resection and primary haemostatic treatment
is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?

Exclusion:

At pre-operative screen

Is there anamnestic or laboratory evidence of coagulation disorders including haemophilia A or B and von Willebrand disease ?
Has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin?
Is the patient undergoing an emergency operation?
Did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial?
Does the patient participate in a clinical trial concomitantly with present trial?

After tumour resection and primary haemostatic treatment
Has any serious surgical complication occurred?
Has any fibrin glue haemostatic (including any type of TachoComb) been used before randomisation?

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290836

Locations

Denmark
Nycomed
Roskilde, Denmark, 4000

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquaters

More Information

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

Study placed in the following topic categories:

Thrombin
Hemorrhage
Aprotinin

ClinicalTrials.gov processed this record on January 16, 2009