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

This study has been completed.
Sponsor:
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00279383
First received: January 12, 2006
Last updated: May 4, 2012
Last verified: January 2009
History of Changes
  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:

U.S. FDA Resources

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

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279383

Locations
Denmark
Nycomed
Roskilde, Denmark
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: NCT00279383     History of Changes
Other Study ID Numbers: TC-022-IT
Study First Received: January 12, 2006
Last Updated: May 4, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Hemostatics
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013