Publications

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't Research Support, N.I.H., Extramural Epublish 3 citations

PubMed: 40152861 DOI: 10.1001/jamanetworkopen.2025.2353

Practical Anemia Bundle and Hemoglobin Recovery in Critical Illness: A Randomized Clinical Trial.

JAMA Netw Open 8(3):e252353

Authors: Matthew A Warner, Matthew L Johnson, Andrew C Hanson, Emma Fortune, Gerald W Flaby, Phillip J Schulte, Valerie M Hazelton, Ronald S Go, W Brian Beam, Jonathan E Charnin, Brenda K Anderson, Brad Karon, Andrea L Cheville, Ognjen Gajic, Daryl J Kor

Affiliations

  • Division of Critical Care Medicine, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota.
  • Anesthesia Clinical Research Unit, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota.
  • Division of Clinical Trials and Biostatistics, Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.
  • Division of Health Care Delivery Research, Mayo Clinic, Rochester, Minnesota.
  • Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.
  • Department of Hematology, Mayo Clinic, Rochester, Minnesota.
  • Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
  • Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota.
  • Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota.

Abstract

Importance

Anemia is a common complication of surgery and acute illness that is associated with adverse clinical outcomes. The role of anemia prevention and treatment strategies in this setting remains unclear.

Objective

To evaluate the effect of a multifaceted anemia management bundle vs standard care on posthospitalization hemoglobin recovery and multidimensional functional outcomes in survivors of acute illness.

Design, Setting, and Participants

This parallel group randomized clinical trial, known as the Practical Anemia Bundle for Sustained Blood Recovery, was conducted at postsurgical and medical intensive care units at a large US medical center. Critically ill patients (aged ≥18 years) with moderate to severe anemia (hemoglobin concentration <10 g/dL) were enrolled between March 2022 and November 2023. Participants were randomly assigned 1:1 to the intervention or standard care group. Intention-to-treat analyses were performed between July 2024 and January 2025.

Intervention

The intervention bundle was delivered throughout the duration of hospitalization and included optimized phlebotomy practices, clinical decision support, and pharmacological anemia treatment with intravenous iron.

Main Outcomes and Measures

The primary outcome was the mean difference in hemoglobin concentration at 1 month after hospital discharge.

Results

A total of 100 patients (median [IQR] age, 68 [61-72] years; 57 men [57.0%]; 65 [65.0%] with postsurgical admission to the intensive care unit) were enrolled during acute illness. Forty-nine patients (49.0%) were assigned to receive the intervention, and 51 (51.0%) were assigned to receive standard care. Hemoglobin concentration at 1 month after discharge was greater in patients receiving the intervention vs standard care (median [IQR], 12.2 [11.8-13.0] g/dL vs 11.5 [10.2-12.6] g/dL; adjusted mean difference, 0.69 [95% CI, 0.13-1.20] g/dL; P = .02).

Conclusions and Relevance

This randomized clinical trial found that a multifaceted anemia prevention and treatment bundle was feasible, was well tolerated, and improved posthospitalization hemoglobin concentrations up to 3 months in critically ill adults. These findings can inform the design of future trials.

Trial Registration

ClinicalTrials.gov Identifier: NCT05167734.

MeSH

Hemoglobins, Hospitalization, Anemia, Recycling, Clinical Medicine, Critical Illness, Therapeutics, Intensive Care Units, Acute Disease