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

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

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
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, see Learn About Clinical Studies.

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

Locations
Denmark
Nycomed
Roskilde, Denmark
Sponsors and Collaborators
Nycomed
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:
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
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014