drugset / Trial / NCT05167734
Practical Anemia Bundle for SusTained Blood Recovery
Phase 2
Completed
100 enrolled
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-11-30
- Primary completion
- 2024-03-04
- Completion
- 2024-11-26
Outcome
Met primary endpoint
paper Hemoglobin concentration at 1 month after discharge was greater in patients receiving the intervention vs standard care PMID 40152861 ↗
paper adjusted mean difference, 0.69 [95% CI, 0.13-1.20] g/dL; P = .02. PMID 40152861 ↗
registry Control (Standard of Care) Group vs Anemia Treatment Bundle; p = 0.02; Mean Difference (Final Values) 0.7 (95% CI 0.1 to 1.2) NCT05167734 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iron dextran | Unknown | 1000 mg | Intravenous |
| Subject | epoetin alfa | Protein / enzyme biologic | 40000 iu | Subcutaneous |