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

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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Key information

Conditions

Blood Loss, Surgical Hemorrhage Hemostasis Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed

Roskilde, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

OSHES (Observational Study on Hemostasis in Surgery ). A Non Interventional Study on the Hemostasis Supportive Methods in Surgery

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Jan 19, 2006
Registry last updated: May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed