Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04920045 |
Other study ID # |
IRB21-0854 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2022 |
Est. completion date |
July 2026 |
Study information
Verified date |
June 2023 |
Source |
University of Chicago |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
The design of this proposed study is a randomized controlled trial of hospitalized adult
general medicine patients with anemia at the University of Chicago (UC). Patients will be
randomized to receive transfusion at either a hemoglobin (Hb)<9g/dL (liberal arm) or a
Hb<7g/dL (restrictive arm) throughout their hospitalization. Self-reported fatigability,
fatigue, and activity levels will be measured in consented patients at randomization and
through a follow-up phone call 7 days after hospital discharge. We will also enroll 150
patients to participate in the Six Minute Walk Test85,86 (6MWT) at randomization and in the
clinic 7 days after hospital discharge.
This trial will test whether a liberal transfusion strategy is superior to a restrictive
transfusion in hospitalized patients with anemia on fatigability levels after hospital
discharge. Our primary outcome is self-reported fatigability level 7 days after hospital
discharge measured using the Pittsburgh Fatigability Scale (PFS)71. Secondary outcomes
include fatigue measured using the Patient Reported Outcome Measurement Information System
(PROMIS) Fatigue Aa instrument, and activity measured by the Physical Activity Scale for the
Elderly, and 6MWT distance.
Eligible patients for this trial will be recruited from the University of Chicago Medical
Center (UCMC) general medicine services using the University of Chicago Hospitalist Project
(UCHP) research infrastructure. The eligibility criteria is: 1) hospitalized adult >18 years
of age, 2) admitted to the general medicine services at the University of Chicago, 3) any Hb
concentration of <9g/dL during their hospitalization. We will exclude patients who: 1)
decline blood transfusion, 2) and/or who have a diagnosis of sickle cell anemia, 3) and/or
are brain dead or receiving only palliative treatment, 4) and/or are unable to follow-up
after discharge. We will not exclude patients who received transfusion prior to
randomization. Eligible patients will be identified using the encrypted UCHP research
database, which is programmed to extract real time EHR data into the database in order to
identify patients potentially eligible for participation in research studies. The PI and
Study Coordinator (SC) will be responsible for patient recruitment and consent.
Consenting patients will be randomized to either receive transfusion when their Hb drops
below 7g/dL (restrictive arm) or 9g/dl (liberal arm) at any point during hospitalization, and
randomized assignment will be done using permuted block design with random blocks of 2, 4, or
6 patients per block. All red blood cell (RBC) transfusions will be administered in 1 unit
increments in order to maintain patients' Hb concentration above the trial arm threshold they
are randomized to. All transfusions will be followed by a Hb measure and an additional
unit(s) of RBC's will only be transfused if there is documentation of the patient's Hb
concentration below the trial arm threshold they are randomized to. However, In the case of
life-threatening bleeding clinicians will be free to transfuse patients without first
checking a patient's Hb concentration. Once randomized, patient's will be managed according
to protocol until hospital discharge independent of transfusion to another service and/or
specialized hospital ward. This trial will not control or dictate transfusion of other blood
products, which will be administered at the discretion of the attending physician caring for
the patient.