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. Identifier: NCT00290836
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : May 7, 2012
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Brief Summary:
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 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)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2004
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Efficacy:
  2. Haemoglobin concentration of drainage fluid on day 1 after surgery.
  3. Haemotocrit concentration of drainage fluid on day 1 after surgery.
  4. Volume of drainage fluid on day 1 after surgery.
  5. Incidence of post-operative haematoma at removal site at day 2 after surgery (sonography).
  6. Incidence of tumour positive resection margin proven by histology (discharge).
  7. Reporting of occurrence of urinary incontinence (discharge, 3 months +/- 10 days (and optional 12 months +/- 30 days) after surgery.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Is the subject 18 years of age or above ?
  3. Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?

    After prostate resection and primary haemostatic treatment

  4. 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)?


At pre-operative screen

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

    After tumour resection and primary haemostatic treatment

  6. Has any serious surgical complication occurred?
  7. Has any fibrin glue haemostatic (including any type of TachoComb) been used before randomisation?

Information from the National Library of Medicine

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 identifier (NCT number): NCT00290836

Roskilde, Denmark, 4000
Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquaters

Responsible Party: Nycomed, Clinical Trial Operations Identifier: NCT00290836     History of Changes
Other Study ID Numbers: TC-017-AU
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action