AnemiaEToFNCT04920045
A Trial to Assess the Effect of Transfusion Strategies on Fatigability Levels After Hospital Discharge
A study testing Red blood cell transfusion in people with Anemia and Red Blood Cell Transfusion, run by University of Chicago at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Red Blood Cell Transfusion, Fatigability
- What is being tested?
- Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Hospitalized on a general medicine service at the University of Chicago
- Any hemoglobin (Hb) concentration <9g/dL
Who cannot join
- Have sickle cell anemia
- Decline blood transfusion
- Are receiving palliative care treatment only
- Are brain dead
- Cannot follow up after hospital discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Comparing a Liberal Versus Restrictive Red Blood Cell Transfusion Strategy on Fatigability, Fatigue, and Activity Levels After Discharge in Hospitalized Patients With Anemia.
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.
Read the detailed 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.
- Conditions
- Anemia, Red Blood Cell Transfusion, Fatigability, Fatigue, Physical Function
- Being tested
- Red blood cell transfusion
- Medical subject headings
- Anemia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionOther
All RBC transfusions will be administered in 1 unit increments 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 able to transfuse patients without first checking a patient's Hb concentration. Once randomized, patients will be man-aged according to protocol until hospital discharge independent of transfer to another service and/or specialized hospital ward.
| Study group | Role | What they receive |
|---|---|---|
| Liberal Transfusion Arm | Active comparator | 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. Receives: Other: Red blood cell transfusion |
| Restrictive Transfusion Arm | Active comparator | 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. Receives: Other: Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported fatigability level
Self-reported fatigability will be measured by the Pittsburgh Fatigability Scale (PFS). The PFS is a 10 item scale that ranges from 0-50 with greater scores indicating greater fatigability.
Measured: Fatigability will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Secondary outcomes (3)
Change in self-reported fatigue level
Self-reported fatigue will be measured by the Patient-Reported Outcome Measurement Information System (PROMIS-F) Fatigue 8a instrument.The PROMIS-F scores range from 8-40, with higher scores indicating greater fatigue.
Measured: Fatigue will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Change in self-reported activity level
Self-reported activity will be measure by the Physical Activity Scale for the Elderly (PASE). Higher scores on the PASE indicated greater physical activity.
Measured: Activity will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Change in 6 Minute Walk Test (6MWT) distance
6MWT is measure of functional capacity
Measured: 6MWT will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Feb 2022
- Primary completion28 Jul 2023
- Study completion26 Mar 2025
Why it stopped: Clinical practice has shifted such that physician equipoise is lacking, stultifying this study's enrollment. While the scientific question remains relevant, data collection and analysis are complete, and no further research activities are planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will occur after patients have consented to participate and will be done using permuted block de-sign with random blocks of 2, 4, or 6 patients per block.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920045
- Sponsor's protocol ID
- IRB21-0854
- Acronym
- EToF
- Status last verified
- Mar 2025
- First submitted
- 24 May 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PubMed 38780066
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing a Liberal Versus Restrictive Red Blood Cell Transfusion Strategy on Fatigability, Fatigue, and Activity Levels After Discharge in Hospitalized Patients With Anemia.
- ClinicalTrials.gov ID
- NCT04920045
- Acronym / sponsor ID
- EToF / IRB21-0854
- Conditions
- Anemia, Red Blood Cell Transfusion, Fatigability, Fatigue, Physical Function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical practice has shifted such that physician equipoise is lacking, stultifying this study's enrollment. While the scientific question remains relevant, data collection and analysis are complete, and no further research activities are planned.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will occur after patients have consented to participate and will be done using permuted block de-sign with random blocks of 2, 4, or 6 patients per block.
| Arm | Type | Receives |
|---|---|---|
| Liberal Transfusion Arm | Active comparator | Other: Red blood cell transfusionPatient'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. |
| Restrictive Transfusion Arm | Active comparator | Other: Red blood cell transfusionPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Hospitalized on a general medicine service at the University of Chicago
- Any hemoglobin (Hb) concentration <9g/dL
Key exclusion criteria (5 listed)
- Have sickle cell anemia
- Decline blood transfusion
- Are receiving palliative care treatment only
- Are brain dead
- Cannot follow up after hospital discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusionAll RBC transfusions will be administered in 1 unit increments 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 able to transfuse patients without first checking a patient's Hb concentration. Once randomized, patients will be man-aged according to protocol until hospital discharge independent of transfer to another service and/or specialized hospital ward. | Other | Liberal Transfusion Arm, Restrictive Transfusion Arm |
Primary outcome
Change in self-reported fatigability level
Time frame: Fatigability will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Self-reported fatigability will be measured by the Pittsburgh Fatigability Scale (PFS). The PFS is a 10 item scale that ranges from 0-50 with greater scores indicating greater fatigability.
3 secondary outcomes
Change in self-reported fatigue level
Time frame: Fatigue will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Change in self-reported activity level
Time frame: Activity will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Change in 6 Minute Walk Test (6MWT) distance
Time frame: 6MWT will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.
Results and safety
The study was stopped early (reason given: Clinical practice has shifted such that physician equipoise is lacking, stultifying this study's enrollment. While the scientific question remains relevant, data collection and analysis are complete, and no further research activities are planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 38780066Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red blood cell transfusion in people with Anemia and Red Blood Cell Transfusion, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Clinical practice has shifted such that physician equipoise is lacking, stultifying this study's enrollment. While the scientific question remains relevant, data collection and analysis are complete, and no further research activities are planned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported fatigability level (time frame: Fatigability will be measured at admission to the hospital during the index hospitalization and 7 days after hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04920045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.