Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00285623
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Nycomed

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Blood Loss, Surgical Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 3000 participants
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.
Study Start Date : December 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
    treatment in surgery for improvement of haemostasis where standard techniques are insufficient

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Layout table for investigator information
Study Chair: Nycomed Clinical Trial Operations Headquarters
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00285623    
Other Study ID Numbers: TC-018-IN
First Posted: February 2, 2006    Key Record Dates
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:
Layout table for MeSH terms
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
 Thrombin
Hemostatics
Coagulants