Red Blood Cells Transfusion for Traumatic Brain Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
James Cook University Hospital, Middlesbrough, United KingdomTraumatic Brain Injury+1 MoreRed Blood Cells Transfusion - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two different transfusion strategies for people with traumatic brain injury. The hypothesis is that a liberal transfusion strategy (transfusing at lower hemoglobin levels) will improve outcomes compared to a restrictive strategy.

Eligible Conditions
  • Traumatic Brain Injury
  • Blood Transfusion

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 6 months

6 months
Complications related to transfusion
Depression (PHQ-9)
Functional Independence Measure (FIM)
Quality of life (EQ-5D)
Quality of life (Qolibri questionnaires)
Return to work/study of patient
extended Glasgow Outcome Scale (GOSe)
Month 6
Mortality

Trial Safety

Trial Design

2 Treatment Groups

Liberal Transfusion Strategy
1 of 2
Restrictive Transfusion Strategy
1 of 2

Experimental Treatment

742 Total Participants · 2 Treatment Groups

Primary Treatment: Red Blood Cells Transfusion · No Placebo Group · N/A

Liberal Transfusion Strategy
Procedure
Experimental Group · 1 Intervention: Red Blood Cells Transfusion · Intervention Types: Procedure
Restrictive Transfusion Strategy
Procedure
Experimental Group · 1 Intervention: Red Blood Cells Transfusion · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
152 Previous Clinical Trials
100,316 Total Patients Enrolled
Canadian Critical Care Trials GroupOTHER
28 Previous Clinical Trials
223,230 Total Patients Enrolled
Canadian Traumatic Brain Injury Research ConsortiumUNKNOWN
1 Previous Clinical Trials
286 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,246 Previous Clinical Trials
24,677,386 Total Patients Enrolled
Canadian Perioperative Anesthesia Clinical Trials (PACT) GroupUNKNOWN
Alexis Turgeon, MD MSc FRCPCPrincipal InvestigatorCHU de Quebec-Université Laval Research Center
1 Previous Clinical Trials
315 Total Patients Enrolled
François Lauzier, MD MSc FRCPCPrincipal InvestigatorCHU de Quebec-Université Laval Research Center
1 Previous Clinical Trials
70 Total Patients Enrolled
Dean Fergusson, PhDPrincipal InvestigatorOttawa Hospital Research Institute
1 Previous Clinical Trials
377 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have recently experienced a serious head injury from a blow or impact.
References

Frequently Asked Questions

How many participants are registering for this research study?

"Affirmative, an examination of clinicaltrials.gov evinces that this medical trial is still looking for participants; it was initially announced on September 1st 2017 and the latest update occurred on August 16th 2022. The experiment hopes to recruit 742 patients from 19 different sites." - Anonymous Online Contributor

Unverified Answer

Where can participants find this research endeavor?

"This medical study is being administered at Centre Hospitalier de l'Université de Montréal in Hamilton, Ontario, Hamilton Health Sciences Center in Ottawa, Saskatchewan and The Ottawa Hospital in Regina, British Columbia as well as 19 other sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.