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.