Blood Loss, Surgical Clinical Trial
Official title:
OSHES (Observational Study on Hemostasis in Surgery ). A Non Interventional Study on the Hemostasis Supportive Methods in Surgery
Verified date | January 2009 |
Source | Nycomed |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 800 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Denmark | Nycomed | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Nycomed |
Denmark,
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