NCT00290836

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Nycomed · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Control of Local Bleeding in Patients Undergoing Prostatectomy.

Interventions

Type	Name	Description
DRUG	Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)

Timeline

• Start date: 2004-05-01
• Completion: 2007-08-01
• First posted: 2006-02-13
• Last updated: 2012-05-07

Locations

1 site across 1 country: Denmark