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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00279383 |
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Date of registration:
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12/01/2006 |
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Primary sponsor: |
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Public title:
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OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)
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Scientific title:
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OSHES (Observational Study on Hemostasis in Surgery ). A Non Interventional Study on the Hemostasis Supportive Methods in Surgery |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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800 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00279383 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Retrospective
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Nycomed Clinical Trial Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Headquarters |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Blood Loss, Surgical
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Hemostasis
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Intervention(s)
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Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
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Secondary ID(s)
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TC-022-IT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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