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

Primary Purpose

Anemia, Critical Illness

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Iron Dextran

Erythropoietin (EPO)

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control (Standard of Care) Group

Anemia Treatment Bundle

Arm Description

Subjects will receive standard clinical care for the treatment of anemia while in the ICU.

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).

Outcomes

Primary Outcome Measures

Hemoglobin concentrations

Mean difference in hemoglobin concentrations

Secondary Outcome Measures

Hemoglobin concentrations

Mean difference in hemoglobin concentrations

Phlebotomy practice

Number of times subjects have blood drawn and total phlebotomy volumes

Patient-Reported Quality of Life

Measured by patient-reported EuroQol (EQ-5D) questionnaire

Anemia-related fatigue

Measured by patient-reported Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (13 questions)

6 minute walk distance

Distance walked in 6 minutes used to assess physical function after critical illness.

Cognitive function after critical illness

Montreal Cognitive Assessment (MoCA-BLIND)

Mental Health - Anxiety and Depression

Hospital Anxiety and Depression Scale (HADS)

Mental Health - Post-Traumatic Distress

Impact of Events Scale-Revised (IES-R)

Allogeneic red blood cell transfusions

Proportion of patients transfused and number of transfused units

Unplanned hospital readmissions

Number of subjects to experience an unplanned hospital readmission

Mortality

Mortality from any cause

Adverse events post-enrollment

Venous thromboembolism, bloodstream infection, myocardial infarction, stroke

Actigraph activity expenditures

Actigraph activity monitor step counts and energy expenditure

Full Information

NCT ID

NCT05167734

First Posted

November 30, 2021

Last Updated

April 25, 2023

Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT05167734

Brief Title

Practical Anemia Bundle for SusTained Blood Recovery

Acronym

PABST-BR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2021 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Critical Illness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control (Standard of Care) Group

Arm Type

No Intervention

Arm Description

Subjects will receive standard clinical care for the treatment of anemia while in the ICU.

Arm Title

Anemia Treatment Bundle

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Iron Dextran

Intervention Description

1000 mg IV

Intervention Type

Drug

Intervention Name(s)

Erythropoietin (EPO)

Other Intervention Name(s)

EPO

Intervention Description

40,000 units subcutaneous

Primary Outcome Measure Information:

Title

Hemoglobin concentrations

Description

Mean difference in hemoglobin concentrations

Time Frame

1 month post-hospitalization

Secondary Outcome Measure Information:

Title

Hemoglobin concentrations

Description

Mean difference in hemoglobin concentrations

Time Frame

Hospital discharge (approximately 1 month) and 3 months post-hospitalization

Title

Phlebotomy practice

Description

Number of times subjects have blood drawn and total phlebotomy volumes

Time Frame

Hospital discharge (approximately 1 month)

Title

Patient-Reported Quality of Life

Description

Measured by patient-reported EuroQol (EQ-5D) questionnaire

Time Frame

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

Title

Anemia-related fatigue

Description

Measured by patient-reported Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (13 questions)

Time Frame

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

Title

6 minute walk distance

Description

Distance walked in 6 minutes used to assess physical function after critical illness.

Time Frame

1 and 3-months post-hospitalization

Title

Cognitive function after critical illness

Description

Montreal Cognitive Assessment (MoCA-BLIND)

Time Frame

1 and 3-months post-hospitalization

Title

Mental Health - Anxiety and Depression

Description

Hospital Anxiety and Depression Scale (HADS)

Time Frame

1 and 3-months post-hospitalization

Title

Mental Health - Post-Traumatic Distress

Description

Impact of Events Scale-Revised (IES-R)

Time Frame

1 and 3-months post-hospitalization

Title

Allogeneic red blood cell transfusions

Description

Proportion of patients transfused and number of transfused units

Time Frame

Hospital discharge (approximately 1 month) and 3-months post-hospitalization

Title

Unplanned hospital readmissions

Description

Number of subjects to experience an unplanned hospital readmission

Time Frame

12-months post-hospitalization

Title

Mortality

Description

Mortality from any cause

Time Frame

12-months post-hospitalization

Title

Adverse events post-enrollment

Description

Venous thromboembolism, bloodstream infection, myocardial infarction, stroke

Time Frame

Hospital discharge (approximately 1 month) and 3-months post-hospitalization

Title

Actigraph activity expenditures

Description

Actigraph activity monitor step counts and energy expenditure

Time Frame

1 and 3-months post-hospitalization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Warner, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Johnson, RRT, LRT

Phone

507-422-2898

johnson.matthew6@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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Practical Anemia Bundle for SusTained Blood Recovery

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