Observational Cohort Study of TachoSil (TC-018-IN)

Completed

• Conditions: Blood Loss, Surgical

• Registration Number: NCT00285623
• Lead Sponsor: Nycomed

Brief Summary

The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. In addition, pharmacoeconomic data will be collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-02
• Primary Completion: 2008-04
• Study Completion: 2008-07
• Status Verified: 2009-07
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• All subjects, treated with TachoSil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed).
• Subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Nycomed; 🇩🇰 Roskilde, Denmark