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OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00279383
First Posted: January 19, 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
OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register settled in Italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques in addition to the standard surgical procedures in 40 surgical wards. The availability of these data will allow for a better understanding of the therapeutic needs in the area of hemostatic supporting agents/techniques.

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: OSHES (Observational Study on Hemostasis in Surgery ). A Non Interventional Study on the Hemostasis Supportive Methods in Surgery

Resource links provided by NLM:


Further study details as provided by Nycomed:

Estimated Enrollment: 800
Study Start Date: August 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
    Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
  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 who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.
Criteria

Inclusion Criteria:

  • Patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.
  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): NCT00279383


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

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00279383     History of Changes
Other Study ID Numbers: TC-022-IT
First Submitted: January 12, 2006
First Posted: January 19, 2006
Last Update Posted: May 7, 2012
Last Verified: January 2009

Keywords provided by Nycomed:
Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures

Additional relevant MeSH terms:
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
Hemostatics
Thrombin
Coagulants