Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR)

The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Illness; Anemia
• Intervention / Treatment: Drug: Iron Dextran; Drug: Erythropoietin (EPO)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (Standard of Care) Group; Subjects will receive standard clinical care for the treatment of anemia while in the ICU.
Experimental: Anemia Treatment Bundle; The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).	Drug: Iron Dextran; 1000 mg IV; Drug: Erythropoietin (EPO); 40,000 units subcutaneous; Other Names: EPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin concentrations	Mean difference in hemoglobin concentrations	1 month post-hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin concentrations	Mean difference in hemoglobin concentrations	Hospital discharge (approximately 1 month) and 3 months post-hospitalization
Phlebotomy practice	Number of times subjects have blood drawn and total phlebotomy volumes	Hospital discharge (approximately 1 month)
Patient-Reported Quality of Life	Measured by patient-reported EuroQol (EQ-5D) questionnaire	Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
Anemia-related fatigue	Measured by patient-reported Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (13 questions)	Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
6 minute walk distance	Distance walked in 6 minutes used to assess physical function after critical illness.	1 and 3-months post-hospitalization
Cognitive function after critical illness	Montreal Cognitive Assessment (MoCA-BLIND)	1 and 3-months post-hospitalization
Mental Health - Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS)	1 and 3-months post-hospitalization
Mental Health - Post-Traumatic Distress	Impact of Events Scale-Revised (IES-R)	1 and 3-months post-hospitalization
Allogeneic red blood cell transfusions	Proportion of patients transfused and number of transfused units	Hospital discharge (approximately 1 month) and 3-months post-hospitalization
Unplanned hospital readmissions	Number of subjects to experience an unplanned hospital readmission	12-months post-hospitalization
Mortality	Mortality from any cause	12-months post-hospitalization
Adverse events post-enrollment	Venous thromboembolism, bloodstream infection, myocardial infarction, stroke	Hospital discharge (approximately 1 month) and 3-months post-hospitalization
Actigraph activity expenditures	Actigraph activity monitor step counts and energy expenditure	1 and 3-months post-hospitalization

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Matthew Warner, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Hematologic Diseases; Critical Illness; Anemia; Anticoagulants; Hematinics; Plasma Substitutes; Blood Substitutes; Epoetin Alfa; Dextrans; Iron-Dextran Complex
• Other Study ID Numbers: 21-006511; K23HL153310-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be shared through the NHLBI Data Repository, which is managed by thenBiologic Specimen and Data Repository Information Coordinating Center (BioLINCC). In addition to study data (e.g. information recorded for each study participant including demographics, clinical characteristics, laboratory assessments, and outcomes / follow-up assessments), study documentation information will also be provided in order to facilitate secondary use of data by investigators not familiar with the original data set. This includes a summary documentation file, manuals of procedures, detailed statistical code, and data dictionary information, among other important documentation. The timing and manner of research data uploading to the Data Repository will be in full compliance with NHLBI guidelines.
• IPD Sharing Time Frame: We commit to providing data immediately upon acceptance of the data for scientific publication or within one year of completion of the award period (whichever comes first).
• IPD Sharing Access Criteria: All published scientific manuscripts will contain information regarding how to request and access study data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No