Practical Anemia Bundle for SusTained Blood Recovery

Mayo Clinic100 enrolled

Overview

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).

Anemia is common during critical illness and is associated with impaired outcomes during and after hospitalization. The goal of this investigation is to test a multi-faceted anemia prevention and targeted treatment bundle to attenuate anemia development and promote functional recovery in the setting of critical illness. Specifically, this will be a pragmatic phase II clinical trial of a multi-faceted anemia prevention and treatment bundle with 3 aspects (optimized phlebotomy practice, clinical decision support, targeted pharmacologic anemia treatment) assessing the impact of the intervention on hemoglobin concentrations (primary aim), transfusion utilization, and functional outcomes through 3 months after hospitalization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Anemia Critical Illness

Interventions

Iron DextranDRUG

1000 mg IV

Erythropoietin (EPO)DRUG

40,000 units subcutaneous

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Hemoglobin Concentrations

Hemoglobin is a protein that cares oxygen through the body

Time frame: 1 month post-hospitalization

Secondary Outcomes

Hemoglobin Concentrations

Hemoglobin is a protein that cares oxygen through the body

Time frame: Hospital discharge (approximately 1 month), 3 months post-hospitalization

Phlebotomy Practice-Blood Draws

Number of times subjects have blood drawn

Time frame: Hospital discharge (approximately 1 month)

Phlebotomy Practice-Volume

Total volume of phlebotomy blood draws

Time frame: Hospital discharge (approximately 1 month)

Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)

The EuroQol (EQ-5D) is a 5-item questionnaire that assess health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total score ranges from 0 to 100, with higher scores indicating improved health.

Time frame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization

Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. Each question is rated on a 4-point scale where 0 represents "very much" fatigued and 4 represents "not at all" fatigued. Total scores range from 0 to 52 with lower scores indicating greater fatigue.

Time frame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization

Data from ClinicalTrials.gov

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