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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285623
First Posted: February 2, 2006
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nycomed
  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:


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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285623


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00285623     History of Changes
Other Study ID Numbers: TC-018-IN
First Submitted: December 21, 2005
First Posted: February 2, 2006
Last Update Posted: May 7, 2012
Last Verified: July 2009

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
Hemorrhage
Pathologic Processes
Intraoperative Complications
Thrombin
Hemostatics
Coagulants