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The Effect of Red Blood Cells Transfusion in Trauma Patients

Sponsor
Progress (Other)
Overall Status
Completed
CT.gov ID
NCT01746953
Collaborator
(none)
20,211
Enrollment
58
Duration (Months)

Study Details

Study Description

Brief Summary

We will evaluate the effect of red blood cell (RBC) transfusion on fatal and non fatal events according to baseline risk of death in an international cohort of trauma patients (CRASH-2 trial). The following outcomes will be considered: death from all causes, death due to bleeding, death due to multiorgan failure, death due to vascular occlusive events and non vascular occlusive events. Non fatal outcomes include: myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Aims: Primary objective: Evaluate the effect of RBC transfusion on all cause mortality according to baseline risk of death due to bleeding. Secondary objectives: Evaluate the effect of RBC transfusion on specific causes of death. Evaluate the effect of RBC transfusion on non fatal vascular occlusive events.

    Sample: Patients from the Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial. The trial included 20,127 trauma patients with, or at risk of, significant bleeding, within 8 hours of injury, and was undertaken in 274 hospitals in 40 countries.

    Outcomes: Death from all causes, death due to bleeding, death due to multiorgan failure, death due to vascular occlusive events and non vascular occlusive events. Vascular occlusive events include: myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. All events were measured at 28 days or hospital discharge Interventions and comparisons: We will compare the effect of red cells transfusion versus no red cells transfusion. We will also evaluate the effect of the number of units of red cells transfusion.

    Methods: We will stratify patients according to baseline risk of death from all causes into four strata (<6%, 6%-20%, 21%-50% and >50%). We will then evaluate the effect of RBC transfusion according to baseline risk on fatal and non fatal outcomes. Formal statistical test to detect heterogeneity will be conducted analyzing baseline risk as a continuous variable.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20211 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Red Blood Cells Transfusion in Trauma Patients: A Risk Stratified Analysis
    Study Start Date :
    May 1, 2005
    Actual Primary Completion Date :
    Feb 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. mortality [30 days]

    Secondary Outcome Measures

    1. fatal and non fatal vascular occlusive events [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients eligible for inclusion in the trial were "adult trauma patients with ongoing significant haemorrhage, within 8 hours of injury."
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Progress

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Progress
    ClinicalTrials.gov Identifier:
    NCT01746953
    Other Study ID Numbers:
    • Progress-06
    • G0902393/99558
    First Posted:
    Dec 11, 2012
    Last Update Posted:
    Dec 11, 2012
    Last Verified:
    Dec 1, 2012
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Dec 11, 2012