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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00279383
Other study ID # TC-022-IT
Secondary ID
Status Completed
Phase Phase 4
First received January 12, 2006
Last updated May 4, 2012
Start date August 2005
Est. completion date April 2008

Study information

Verified date January 2009
Source Nycomed
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Drug:
Fibrinogen (human) + thrombin (human) (TachoSil)
Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures

Locations

Country Name City State
Denmark Nycomed Roskilde

Sponsors (1)

Lead Sponsor Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

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