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Clinical Trials/NCT01746953
NCT01746953
Completed
Not Applicable

The Effect of Red Blood Cells Transfusion in Trauma Patients: A Risk Stratified Analysis

Progress0 sites20,211 target enrollmentMay 2005
ConditionsTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
Progress
Enrollment
20211
Primary Endpoint
mortality
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
March 2010
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Progress
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients eligible for inclusion in the trial were "adult trauma patients with ongoing significant haemorrhage, within 8 hours of injury."

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

mortality

Time Frame: 30 days

Secondary Outcomes

  • fatal and non fatal vascular occlusive events(30 days)

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