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Whole Blood Transfusion for Trauma Patients
Phase 3
Waitlist Available
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post ed admission
Awards & highlights
Summary
This trial is looking at whether or not adult male patients who are brought to the emergency department as Level A trauma activations and are receiving emergency blood transfusion benefit from receiving more blood.
Eligible Conditions
- Acute Blood Loss Anemia
- Hemorrhagic Shock
- Traumatic Brain Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours post ed admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours post ed admission
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
pRBC equivalents transfused
Secondary outcome measures
Mortality
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Low Titer O+ Whole BloodExperimental Treatment1 Intervention
Low Titer O+ Whole blood provided to Level A trauma patients
Group II: Component TherapyActive Control1 Intervention
Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Routine labs
2022
Completed Phase 3
~210
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
308 Previous Clinical Trials
260,919 Total Patients Enrolled
1 Trials studying Anemia
299 Patients Enrolled for Anemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients who were declared dead upon arrival to the trauma bay.Adult men brought to the emergency room as severe trauma cases and receiving emergency blood transfusions.
Research Study Groups:
This trial has the following groups:- Group 1: Low Titer O+ Whole Blood
- Group 2: Component Therapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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