drugset / Trial / NCT00290836

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

NCT00290836

Phase 4 Completed 120 enrolled Nycomed
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-05
Primary completion
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprotinin Unknown
Subject Fibrinogen Concentrate Human Protein / enzyme biologic
Subject thrombin Protein / enzyme biologic

Indications

No indication recorded.