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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Loss, Surgical Hemostasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Fibrinogen (human) + thrombin (human) (TachoSil)

Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No