Text Size

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

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

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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285623

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov 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: A Takeda Company:
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:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on June 17, 2013