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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03379285
Other study ID # HDréa
Secondary ID
Status Completed
Phase N/A
First received November 23, 2017
Last updated December 15, 2017
Start date October 3, 2016
Est. completion date December 31, 2016

Study information

Verified date October 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Gastro intestinal (GI) bleeding is relatively frequent and may lead to intensive care unit admission. Although a restrictive strategy for red blood cell transfusion is supported by a large randomized controlled trial literature, less is known about the impact of transfusion strategy of other blood components and administration of anti fibrinolytic on clinical outcomes.

This study aims to identify parameters that may be associated with the risk of further bleeding in patients admitted to ICU for GI bleeding.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with Gastro Intestinal Bleeding admitted to either medical or surgical intensive care unit

Exclusion Criteria:

- patients retrieved from another hospital

- age < 18 years consent withdrawal

Study Design


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bleeding Bleeding persistance or recidive requiring an intervention or a scope within a week
Secondary mortality hospital mortality during hospitalisation (28 days)
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