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

May 4, 2012 updated by: Nycomed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)?

Exclusion:

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?

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nycomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

December 16, 2005

First Submitted That Met QC Criteria

February 10, 2006

First Posted (ESTIMATE)

February 13, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-017-AU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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