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

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized controlled trial in which hospitalized patients with anemia are randomized to receive transfusion at: a) Hb\<9g/dL (liberal transfusion strategy), or b) Hb\<7g/dL (restrictive transfusion strategy). We are measuring self-reported fatigability, fatigue, and activity levels at randomization and 7 days post hospital discharge in both trial arms. In a subset of 75 patients in each trial arm (150 total), we will are administering the 6 Minute Walk Test at randomization and 7 days post discharge.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+