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

NCT00290836 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-05-07

No results posted yet for this study

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

DRUG

Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)

Sponsors & Collaborators

  • Nycomed

    lead INDUSTRY

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquaters

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2007-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290836 on ClinicalTrials.gov