Clinical Trials

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 iron or erythropoiesis stimulating agent (ESA) use (i.e.
darbepoetin, Aranesp, erythropoietin, Epogen, Procrit, Retacrit) within 30 days of
enrollment, exclusive of oral iron for general nutritional support (e.g. multivitamin
with iron)

- 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.