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

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

Condition Intervention Phase
Blood Loss, Surgical
Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Nycomed:

Enrollment: 3000
Study Start Date: December 2005
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
    treatment in surgery for improvement of haemostasis where standard techniques are insufficient

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients exposed to TachoSil® of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00285623

Roskilde, Denmark, 4000
Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

Responsible Party: Nycomed, Clinical Trial Operations Identifier: NCT00285623     History of Changes
Other Study ID Numbers: TC-018-IN 
Study First Received: December 21, 2005
Last Updated: May 4, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: National Health Service
Spain: Spanish Agency of Medicines

Keywords provided by Nycomed:
Collection of all thromboembolic events,
immunological events and drug interactions leading to thromboembolic events or major
bleeding after exposure to TachoSil®.

Additional relevant MeSH terms:
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Coagulants processed this record on December 09, 2016