Practical Anemia Bundle for SusTained Blood Recovery

NCT ID: NCT05167734

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2024-11-26

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).

Detailed Description

Anemia is common during critical illness and is associated with impaired outcomes during and after hospitalization. The goal of this investigation is to test a multi-faceted anemia prevention and targeted treatment bundle to attenuate anemia development and promote functional recovery in the setting of critical illness. Specifically, this will be a pragmatic phase II clinical trial of a multi-faceted anemia prevention and treatment bundle with 3 aspects (optimized phlebotomy practice, clinical decision support, targeted pharmacologic anemia treatment) assessing the impact of the intervention on hemoglobin concentrations (primary aim), transfusion utilization, and functional outcomes through 3 months after hospitalization.

Conditions

Anemia; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control (Standard of Care) Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Anemia Treatment Bundle

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).

Group Type: EXPERIMENTAL

Iron Dextran

Intervention Type: DRUG

1000 mg IV

Erythropoietin (EPO)

Intervention Type: DRUG

40,000 units subcutaneous

Interventions

Iron Dextran

1000 mg IV

Intervention Type: DRUG

Erythropoietin (EPO)

40,000 units subcutaneous

Intervention Type: DRUG

Other Intervention Names

EPO

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew A. Warner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Warner, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40152861 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36460332 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23HL153310-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-006511

Identifier Type: -

Identifier Source: org_study_id