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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00285623
First received: December 21, 2005
Last updated: May 4, 2012
Last verified: July 2009

December 21, 2005
May 4, 2012
December 2005
April 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00285623 on ClinicalTrials.gov Archive Site
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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.

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Patients exposed to TachoSil® of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.

Blood Loss, Surgical
Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
treatment in surgery for improvement of haemostasis where standard techniques are insufficient
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
July 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00285623
TC-018-IN
Yes
Nycomed, Clinical Trial Operations
Nycomed
Not Provided
Study Chair: Nycomed Clinical Trial Operations Headquarters
Nycomed
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP