NCT01746953

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

4.8 years

First QC Date

December 7, 2012

Last Update Submit

December 10, 2012

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

  • mortality

    30 days

Secondary Outcomes (1)

  • fatal and non fatal vascular occlusive events

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Perel P, Clayton T, Altman DG, Croft P, Douglas I, Hemingway H, Hingorani A, Morley KI, Riley R, Timmis A, Van der Windt D, Roberts I; PROGRESS Partnership. Red blood cell transfusion and mortality in trauma patients: risk-stratified analysis of an observational study. PLoS Med. 2014 Jun 17;11(6):e1001664. doi: 10.1371/journal.pmed.1001664. eCollection 2014 Jun.

    PMID: 24937305DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

May 1, 2005

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

December 11, 2012

Record last verified: 2012-12