Trials / Completed
CompletedNCT00440401
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
A Randomised, Open Label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety of TachoSil® Versus Standard Haemostatic Treatment in Cardiovascular Surgery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Nycomed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fibrinogen (human) + thrombin (human) | |
| DRUG | Standard haemostatic treatment in cardiovascular surgery | Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®) |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2007-08-01
- Completion
- 2007-11-01
- First posted
- 2007-02-27
- Last updated
- 2012-05-08
- Results posted
- 2010-06-04
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00440401. Inclusion in this directory is not an endorsement.