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OpenTrials
Completed

NCT Number: NCT00290836

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

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.

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Key information

Conditions

Control of Local Bleeding in Patients Undergoing Prostatectomy.

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nycomed

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2007
First posted
Feb 13, 2006
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.