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Completed

NCT Number: NCT01746953

The Effect of Red Blood Cells Transfusion in Trauma Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: 30 days

Secondary outcomes

  1. fatal and non fatal vascular occlusive events

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Progress

Network

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2012
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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