Transfusion Strategies for Anemia (EToF Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Approved in 1 jurisdiction

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

I am 18 years old or older.

Exclusion 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.

Treatment Details

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.

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.