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Blood Product

Transfusion Strategies for Anemia (EToF Trial)

N/A

Waitlist Available

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

Must not have

Cannot follow up after hospital discharge

Have sickle cell anemia

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot attend follow-up visits after leaving the hospital.

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I have sickle cell anemia.

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I refuse to receive blood transfusions.

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I am only receiving treatment to ease cancer symptoms.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and fatigability will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in self-reported fatigability level

Secondary study objectives

Change in 6 Minute Walk Test (6MWT) distance

Change in self-reported activity level

Change in self-reported fatigue level

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met