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The Effect of Red Blood Cells Transfusion in Trauma Patients

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ClinicalTrials.gov Identifier: NCT01746953
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Progress

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
Trauma

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 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 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

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Primary Outcome Measures :
  1. mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. fatal and non fatal vascular occlusive events [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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:


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Progress
ClinicalTrials.gov Identifier: NCT01746953     History of Changes
Other Study ID Numbers: Progress-06
G0902393/99558 ( Other Grant/Funding Number: MRC )
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Wounds and Injuries