Practical Anemia Bundle for SusTained Blood Recovery

NCT05167734 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 21-006511K23HL153310-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a multi-faceted anemia treatment plan to reduce the severity of anemia and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).

Conditions

Anemia; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Concentrations

  Hemoglobin is a protein that cares oxygen through the body

  1 month post-hospitalization

Secondary Outcomes (16)

• Hemoglobin Concentrations

  Hospital discharge (approximately 1 month), 3 months post-hospitalization

• Phlebotomy Practice-Blood Draws

  Hospital discharge (approximately 1 month)

• Phlebotomy Practice-Volume

  Hospital discharge (approximately 1 month)

• Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)

  Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization

• Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

  Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization

Study Arms (2)

Control (Standard of Care) Group

NO INTERVENTION

Subjects will receive standard clinical care for the treatment of anemia while in the ICU.

Anemia Treatment Bundle

EXPERIMENTAL

The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).

Drug: Iron Dextran; Drug: Erythropoietin (EPO)

Interventions

Iron Dextran DRUG

1000 mg IV

Anemia Treatment Bundle

Erythropoietin (EPO) DRUG

40,000 units subcutaneous

Also known as: EPO

Anemia Treatment Bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form (may be completed by legal proxies for those patients unable to provide consent, i.e. sedation/intubation)
• Stated willingness to comply with all study procedures and availability for the duration of the study, including follow-up assessments
• Current ICU admission at Mayo Clinic Rochester with anticipated ICU duration \>48 hours after enrollment
• Current ICU duration \< 7 days
• Patients embedded in the local or regional Mayo Clinic Health System to facilitate post-hospitalization outcome assessment
• Moderate-to-severe anemia (i.e. hemoglobin concentration \< 10 g/dL) at the time of enrollment, with the hemoglobin concentration assessed no more than 24 hours prior to enrollment. If RBC transfusion has been administered between the qualifying hemoglobin assessment and enrollment, a repeat hemoglobin will be required prior to enrollment to ensure that it remains \< 10 g/dL.

You may not qualify if:

• Recent or current IV iron or erythropoiesis stimulating agent (ESA) use (i.e. darbepoetin, Aranesp, erythropoietin, Epogen, Procrit, Retacrit) within 30 days of enrollment
• Severe anemia prior to hospitalization (i.e. hemoglobin \<9 g/dL within 90 days of admission)
• Known allergic reactions to iron or EPO
• Inability to complete outcome assessments (i.e. not expected to survive hospitalization, unable to make follow-up appointments, non-ambulatory, dementia or other severe cognitive impairment, visual impairment i.e. blind or legally blind)
• Pregnancy or breastfeeding at time of enrollment
• Inability to receive pharmacologic venous thromboembolic prophylaxis except in patients with recent surgical or gastrointestinal bleeding
• Active or suspected thrombosis (i.e. deep venous thrombosis, pulmonary embolism, acute arterial thrombus within 3 months)
• Uncontrolled sepsis (i.e. \<48 hours of appropriate antimicrobial therapy and/or lack of definitive source control)
• Having received ≥10 units of allogeneic RBCs in the 48 hours before enrollment
• Acute coronary syndrome or ischemic stroke within 3 months
• Weight less than 40 kg
• Concerns with study enrollment expressed by the clinical team
• Mechanical circulatory support devices

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Warner MA, Johnson ML, Hanson AC, Fortune E, Flaby GW, Schulte PJ, Hazelton VM, Go RS, Beam WB, Charnin JE, Anderson BK, Karon B, Cheville AL, Gajic O, Kor DJ. Practical Anemia Bundle and Hemoglobin Recovery in Critical Illness: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e252353. doi: 10.1001/jamanetworkopen.2025.2353.

  PMID: 40152861 DERIVED

• Warner MA, Go RS, Schulte PJ, Beam WB, Charnin JE, Meade L, Droege KA, Anderson BK, Johnson ML, Karon B, Cheville A, Gajic O, Kor DJ. Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial. BMJ Open. 2022 Dec 2;12(12):e064017. doi: 10.1136/bmjopen-2022-064017.

  PMID: 36460332 DERIVED

MeSH Terms

Conditions

Anemia; Critical Illness

Interventions

Iron-Dextran Complex; Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Matthew Warner, M.D.
• Organization: Mayo Clinic

Warner.Matthew@mayo.edu

507-422-1714

Study Officials

• Matthew Warner, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 22, 2021
• Study Start: November 30, 2021
• Primary Completion: March 4, 2024
• Study Completion: November 26, 2024
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: We commit to providing data immediately upon acceptance of the data for scientific publication or within one year of completion of the award period (whichever comes first).
• Access Criteria: All published scientific manuscripts will contain information regarding how to request and access study data.

Locations

US (1)