Clinical trial NCT05167734: Practical Anemia Bundle for SusTained Blood Recovery
Official title: The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Critical Illness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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

Primary outcomes:
measure: Hemoglobin Concentrations
timeFrame: 1 month post-hospitalization
Secondary outcomes:
measure: Hemoglobin Concentrations
timeFrame: Hospital discharge (approximately 1 month), 3 months post-hospitalization
measure: Phlebotomy Practice-Blood Draws
timeFrame: Hospital discharge (approximately 1 month)
measure: Phlebotomy Practice-Volume
timeFrame: Hospital discharge (approximately 1 month)
measure: Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)
timeFrame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
measure: Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
timeFrame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
measure: 6 Minute Walk Distance
timeFrame: 1 and 3-months post-hospitalization
measure: Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)
timeFrame: 1 and 3-months post-hospitalization
measure: Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS)
timeFrame: 1 and 3-months post-hospitalization
measure: Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)
timeFrame: 1 and 3-months post-hospitalization
measure: Number of Participants With Allogeneic Red Blood Cell Transfusions
timeFrame: 3-months post-hospitalization
measure: Number of Transfused Units of Allogeneic Red Blood Cells
timeFrame: 3 months post hospitalization
measure: Unplanned Hospital Readmissions
timeFrame: 3 months and 12-months post-hospitalization
measure: Mortality
timeFrame: 3 months and 12-months post-hospitalization
measure: Adverse Events Post-enrollment
timeFrame: Hospital discharge (approximately 1 month), 3-months post-hospitalization
measure: Accelerometry-measured Number of Steps Taken Per Day
timeFrame: 1 and 3-months post-hospitalization
measure: Accelerometry-measured Daily Maximum Step Cadence
timeFrame: 1 month and 3 month post hospitalization
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Warner, MD
role: PRINCIPAL_INVESTIGATOR
References: