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Blood Product
Transfusion Strategies for Anemia (EToF Trial)
N/A
Recruiting
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6mwt will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Awards & highlights
EToF Trial Summary
This trial is testing whether restrictive transfusions (at Hb<7g/dL) are as effective as liberal transfusions (at Hb<9g/dL) in reducing fatigue and improving activity levels in hospitalized patients with anemia.
Who is the study for?
This trial is for adults over 18 with anemia who are hospitalized at the University of Chicago and have a hemoglobin level below 9g/dL. It's not for those who refuse blood transfusions, can't do follow-ups after leaving the hospital, have sickle cell anemia, are only getting palliative care, or are brain dead.Check my eligibility
What is being tested?
The study compares two blood transfusion strategies in anemic patients: one gives transfusions when hemoglobin drops below 9g/dL (liberal), and the other below 7g/dL (restrictive). We're checking how tired they feel and their activity levels right after treatment and a week later.See study design
What are the potential side effects?
Red blood cell transfusions may cause allergic reactions, fever, iron overload in long-term cases, lung injury from fluid overload (TACO), or immune system reactions.
EToF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
EToF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ fatigability will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fatigability will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in self-reported fatigability level
Secondary outcome measures
Change in 6 Minute Walk Test (6MWT) distance
Change in self-reported activity level
Change in self-reported fatigue level
EToF Trial Design
2Treatment groups
Active Control
Group I: Liberal Transfusion ArmActive Control1 Intervention
Patient's in the liberal transfusion arm will receive a 1 unit RBC transfusion following randomization and will re-ceive blood in additional 1 unit increments until their Hb is above 9g/dL. At any point during the patient's hospital-ization if their Hb subsequently falls below 9g/dL, they will again be transfused to maintain a Hb>9g/dL, and this will be maintained throughout their hospitalization.
Group II: Restrictive Transfusion ArmActive Control1 Intervention
Patients in the restrictive transfusion arm will receive transfusion if their Hb concentration falls below 7g/dL. RBC's will be administered 1 unit at a time and enough blood will be given to increase patient's Hb to above 7g/dL.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,012 Previous Clinical Trials
733,322 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot attend follow-up visits after leaving the hospital.I have sickle cell anemia.I refuse to receive blood transfusions.I am only receiving treatment to ease cancer symptoms.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Liberal Transfusion Arm
- Group 2: Restrictive Transfusion Arm
Awards:
This trial has 1 awards, including:- 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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