Transfusion Strategies for Anemia

(EToF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Sickle cell anemia, Palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Duration of hospitalization

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates two strategies for administering blood transfusions to hospital patients with anemia, a condition characterized by insufficient healthy red blood cells. One group receives transfusions when hemoglobin levels drop below 9g/dL, while the other group receives them when levels fall below 7g/dL. The study measures how these strategies impact fatigue and activity levels, and some participants will also complete a short walking test. This trial may suit individuals who have been hospitalized, have anemia with a hemoglobin level under 9g/dL, and are not dealing with sickle cell anemia or receiving only palliative care. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve anemia treatment strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that red blood cell transfusions, like those in this trial, have been tested for safety in other studies. One study found that a liberal transfusion strategy, which involves giving more blood, can lower the risk of heart attacks but might increase the risk of lung problems. Another study found that a restrictive transfusion strategy, which involves giving less blood, reduces the overall need for transfusions.

Both approaches have been compared, and using less blood might not affect the risk of death compared to using more. The choice between these strategies often depends on the patient's specific health needs. Generally, red blood cell transfusions are a common and safe practice in hospitals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the transfusion strategies being explored for anemia because they aim to optimize blood transfusions to improve patient outcomes. Unlike the traditional approach that often targets a standard hemoglobin level for all patients, the liberal transfusion strategy provides more personalized care by transfusing patients when their hemoglobin drops below 9g/dL, potentially reducing symptoms of anemia more quickly. On the other hand, the restrictive transfusion arm only administers blood when hemoglobin levels fall below 7g/dL, which could minimize the risks associated with transfusions, such as infections or transfusion reactions. By comparing these two strategies, researchers hope to determine which approach is more beneficial for patient safety and recovery.

What evidence suggests that this trial's transfusion strategies could be effective for anemia?

This trial will compare liberal and restrictive red blood cell transfusion strategies for treating anemia. Research has shown that both strategies work similarly well. Studies found that using more blood (liberal strategy) does not significantly lower risks compared to using less blood (restrictive strategy). A restrictive approach reduces the number of transfusions needed without affecting patient survival. Both strategies do not significantly change death rates for patients with anemia. For specific conditions like heart attacks, the benefits of each strategy can differ, but overall results remain similar. In general, both strategies are effective, with neither showing a clear advantage in many cases. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Hospitalized on a general medicine service at the University of Chicago

Any hemoglobin (Hb) concentration <9g/dL

Exclusion Criteria

Are brain dead

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

I have sickle cell anemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive either a liberal or restrictive transfusion strategy during hospitalization

Duration of hospitalization

Inpatient care

Follow-up

Participants are monitored for fatigability, fatigue, and activity levels 7 days post hospital discharge

1 week

1 follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

• Red blood cell transfusion

Trial Overview 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.

How Is the Trial Designed?

Group I: Liberal Transfusion Arm Active Control 1 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 Arm Active Control 1 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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307983

Restrictive or Liberal Transfusion Strategy in Myocardial ... Our results show that in patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060722/

Liberal versus restrictive red blood cell transfusion strategy in ... Our meta-analysis demonstrated that a liberal RBC transfusion strategy reduced the risk of MI and increased the risk of acute lung injury but did not affect ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2776201

Effect of a Restrictive vs Liberal Blood Transfusion Strategy ... This noninferiority trial compares the effects of a restrictive (hemoglobin ≤8 g/dL) vs liberal (hemoglobin ≤10 g/dL) transfusion strategy ...

4. aob.amegroups.org aob.amegroups.org/article/view/11039/html

Impact of red blood cell transfusion on patient's quality of life Both transfusions and postoperative anemia are associated with increased morbidity, heightened cardiovascular risks, and prolonged hospital ...

5. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/5573/506194/Restrictive-Versus-Liberal-Red-Blood-Cell

Restrictive Versus Liberal Red Blood Cell Transfusion ... Overall, a restrictive RBC transfusion strategy may result in little to no difference in the risk of death at 31 to 100 days compared to a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34932836/

Transfusion thresholds for guiding red blood cell transfusion Restrictive transfusion strategies reduced the risk of receiving at least one RBC transfusion by 41% across a broad range of clinical contexts ...

7. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1457400/full

Liberal versus restrictive red blood cell transfusion strategy ... Our meta-analysis demonstrated that a liberal RBC transfusion strategy reduced the risk of MI and increased the risk of acute lung injury.

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.124.010957

Risks of Restrictive Versus Liberal Red Blood Cell ... Risks of restrictive versus liberal red blood cell transfusion strategies in patients with cardiovascular disease: an updated meta-analysis.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11872679/

Efficacy and Safety of Blood Transfusion Protocols in the ... This review assesses the efficacy and safety of a restrictive versus liberal blood transfusion strategy in AMI patients.