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HDréa: Management of Digestive Haemorrhaging In CHRU of Brest During 2009 and 2014

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03379285
Collaborator
(none)
272
Enrollment
1
Location
2.9
Actual Duration (Months)
93
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    272 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors for Further Bleeding in Patients Admitted to Intensive Care for Gastro Intestinal Bleeding
    Actual Study Start Date :
    Oct 3, 2016
    Actual Primary Completion Date :
    Dec 31, 2016
    Actual Study Completion Date :
    Dec 31, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Bleeding [within a week]

      Bleeding persistance or recidive requiring an intervention or a scope

    Secondary Outcome Measures

    1. mortality [during hospitalisation (28 days)]

      hospital mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03379285
    Other Study ID Numbers:
    • HDréa
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Dec 20, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Gastro Intestinal Bleeding;
    Transfusion,
    Outcomes
    Additional relevant MeSH terms:
    Gastrointestinal Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Dec 20, 2017