Phase 2
N=100
Practical Anemia Bundle for SusTained Blood Recovery
Anemia · Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT05167734 ↗Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Apr 2025
Primary outcome: Primary: Hemoglobin Concentrations — 11.5; 12.2 g/dL — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Iron Dextran (Drug); Erythropoietin (EPO) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2024
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 | — |
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).
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.