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TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)

NCT00440401 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-05-08

Study results available
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Summary

To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery

Conditions

  • Haemorrhage
  • Haemostasis
  • Cardiovascular Surgery

Interventions

DRUG

fibrinogen (human) + thrombin (human)

DRUG

Standard haemostatic treatment in cardiovascular surgery

Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-08-31
Completion
2007-11-30

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 NCT00440401 on ClinicalTrials.gov