Observational Cohort Study of TachoSil (TC-018-IN)
An Non-interventional, Prospective, Non-controlled Study of the Use of TachoSil in Supportive Treatment in Surgery for Improvement of Haemostasis Where Standard Techniques Are Insufficient.
1 other identifier
observational
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2005
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 21, 2005
CompletedFirst Posted
Study publicly available on registry
February 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMay 7, 2012
July 1, 2009
2.3 years
December 21, 2005
May 4, 2012
Conditions
Keywords
Interventions
treatment in surgery for improvement of haemostasis where standard techniques are insufficient
Eligibility Criteria
Patients exposed to TachoSil® of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nycomedlead
Study Sites (1)
Nycomed
Roskilde, 4000, Denmark
Related Publications (1)
Birth M, Figueras J, Bernardini S, Troen T, Gunther K, Mirza D, Mortensen FV. Collagen fleece-bound fibrin sealant is not associated with an increased risk of thromboembolic events or major bleeding after its use for haemostasis in surgery: a prospective multicentre surveillance study. Patient Saf Surg. 2009 Jun 22;3(1):13. doi: 10.1186/1754-9493-3-13.
PMID: 19545437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nycomed Clinical Trial Operations
Headquarters
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 21, 2005
First Posted
February 2, 2006
Study Start
December 1, 2005
Primary Completion
April 1, 2008
Study Completion
July 1, 2008
Last Updated
May 7, 2012
Record last verified: 2009-07