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Blood Transfusion Strategies for Traumatic Brain Injury (HEMOTION Trial)

N/A

Waitlist Available

Led By Alexis Turgeon, MD MSc FRCPC

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute moderate to severe blunt TBI

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

HEMOTION Trial 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.

Who is the study for?

The HEMOTION Trial is for patients with moderate to severe blunt traumatic brain injury (TBI), who have a Glasgow Coma Score of 12 or less and low hemoglobin levels. It's not for those already given transfusions after ICU admission, with contraindications to transfusions, active major bleeding, life-sustaining therapy withdrawal decisions, no fixed address, or are brain dead.Check my eligibility

What is being tested?

This trial tests if different thresholds for giving red blood cell transfusions affect recovery from TBI. Patients will be randomly assigned to receive transfusions either at higher ('liberal') or lower ('restrictive') hemoglobin levels to see which strategy leads to better neurological function.See study design

What are the potential side effects?

Red blood cell transfusion can cause allergic reactions, fever, lung injury related to the infusion (TRALI), iron overload in the body over time with multiple transfusions, and increased risk of infections.

HEMOTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a recent severe head injury from a blunt force.

HEMOTION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

extended Glasgow Outcome Scale (GOSe)

Secondary outcome measures

Complications related to transfusion

Depression (PHQ-9)

Functional Independence Measure (FIM)

+3 more

HEMOTION Trial Design

2Treatment groups

Experimental Treatment

Group I: Restrictive Transfusion StrategyExperimental Treatment1 Intervention

Patients will receive red blood cells transfusion if Hb ≤ 70 g/L.

Group II: Liberal Transfusion StrategyExperimental Treatment1 Intervention

Patients will receive red blood cells transfusion if Hb ≤ 100 g/L.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

106,415 Total Patients Enrolled

Canadian Critical Care Trials GroupOTHER

30 Previous Clinical Trials

227,543 Total Patients Enrolled

Canadian Traumatic Brain Injury Research ConsortiumUNKNOWN

1 Previous Clinical Trials

286 Total Patients Enrolled

Media Library

Red Blood Cells Transfusion Clinical Trial Eligibility Overview. Trial Name: NCT03260478 — N/A

Traumatic Brain Injury Research Study Groups: Liberal Transfusion Strategy, Restrictive Transfusion Strategy

Traumatic Brain Injury Clinical Trial 2023: Red Blood Cells Transfusion Highlights & Side Effects. Trial Name: NCT03260478 — N/A

Red Blood Cells Transfusion 2023 Treatment Timeline for Medical Study. Trial Name: NCT03260478 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

Dr Alexis Turgeon 2017. "HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03260478.

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