TraumaNCT01746953
The Effect of Red Blood Cells Transfusion in Trauma Patients
An observational study of Trauma, run by Progress.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- How many people
- 20,211 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients eligible for inclusion in the trial were "adult trauma patients with ongoing significant haemorrhage, within 8 hours of injury."
Who cannot join
None listed.
About this study
Official title: The Effect of Red Blood Cells Transfusion in Trauma Patients: A Risk Stratified Analysis
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.
Read the 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.
- Conditions
- Trauma
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 30 days
Secondary outcomes (1)
fatal and non fatal vascular occlusive events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startMay 2005
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progress
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746953
- Sponsor's protocol ID
- Progress-06
- Other IDs
- G0902393/99558
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24937305
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Red Blood Cells Transfusion in Trauma Patients: A Risk Stratified Analysis
- ClinicalTrials.gov ID
- NCT01746953
- Acronym / sponsor ID
- Progress-06
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,211 participants (actual)
- Lead sponsor
- ProgressResearch network
- Study start
- May 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients eligible for inclusion in the trial were "adult trauma patients with ongoing significant haemorrhage, within 8 hours of injury."
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: 30 days
1 secondary outcome
fatal and non fatal vascular occlusive events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Derived from this study: PubMed 24937305Perel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Progress.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01746953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.