Phase 2
Completed N=100
Practical Anemia Bundle for SusTained Blood Recovery
Source: ClinicalTrials.gov NCT05167734 ↗Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Apr 2025
Primary outcomePrimary: Hemoglobin Concentrations — 11.5; 12.2 g/dL — p=0.02
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Concentrations |
9.0; 9.6; 12.8; 13.4 | 0.04 sig |
| SECONDARY Hemoglobin Concentrations |
9.0; 9.6; 12.8; 13.4 | 0.04 sig |
| SECONDARY Phlebotomy Practice-Blood Draws |
46; 32 | 0.352 |
| SECONDARY Phlebotomy Practice-Volume |
142; 32 | <0.001 sig |
| SECONDARY Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) |
60; 51; 65; 70; 80; 80 | 0.94 |
| SECONDARY Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale |
28; 32; 37; 41; 44; 46 | 0.23 |
| SECONDARY 6 Minute Walk Distance |
1080; 1211; 1208; 1220 | 0.13 |
| SECONDARY Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) |
19; 20; 20; 21 | 0.12 |
| SECONDARY Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) |
2; 1; 1; 0; 4; 2 | 0.29 |
| SECONDARY Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) |
1; 3; 0; 0 | 0.56 |
| SECONDARY Number of Participants With Allogeneic Red Blood Cell Transfusions |
6; 1 | 0.09 |
| SECONDARY Number of Transfused Units of Allogeneic Red Blood Cells |
0; 0 | — |
| SECONDARY Unplanned Hospital Readmissions |
16; 12; 30; 24 | 0.48 |
| SECONDARY Mortality |
1; 2; 2; 3 | 0.54 |
| SECONDARY Adverse Events Post-enrollment |
4; 2; 2; 0; 2; 1 | — |
| SECONDARY Accelerometry-measured Number of Steps Taken Per Day |
6481; 6017; 8281; 6874 | — |
| SECONDARY Accelerometry-measured Daily Maximum Step Cadence |
67.0; 64.4; 71.1; 61.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT05167734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.