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Erythropoiesis-Stimulating Agent

Anemia Bundle for Anemia (PABST-BR Trial)

Phase 2

Waitlist Available

Led By Matthew Warner, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Current ICU duration < 7 days

Must not have

Weight less than 40 kg

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new way to treat anemia that could help reduce severity and promote recovery.

Who is the study for?

This trial is for adults in the ICU at Mayo Clinic Rochester with moderate-to-severe anemia, expected to stay over 48 hours post-enrollment. They must have a hemoglobin level below 10 g/dL and be within their first week of ICU care. Excluded are those with uncontrolled sepsis, mechanical heart devices, severe pre-hospitalization anemia, allergies to iron or EPO, pregnant/breastfeeding women, recent thrombosis history, underweight individuals (less than 40 kg), and those unable to follow up.

What is being tested?

The study tests a treatment bundle including Iron Dextran and Erythropoietin (EPO) aimed at reducing anemia severity and aiding recovery in critically ill patients. It evaluates how well this combination helps increase hemoglobin levels compared to standard care.

What are the potential side effects?

Possible side effects from Iron Dextran include muscle cramps, nausea, dizziness or fainting; while Erythropoietin may cause hypertension or blood clots. Allergic reactions can occur but only participants without known allergies to these drugs are included.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hemoglobin level is below 10 g/dL, and I have moderate-to-severe anemia.

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I have been in the ICU for less than 7 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 40 kg.

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I am able to attend follow-up appointments and complete assessments.

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I have received 10 or more blood transfusions in the last 2 days.

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I have not had a blood clot in the past 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization

This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

6 minute walk distance

Actigraph activity expenditures

Adverse events post-enrollment

+10 more

Side effects data

From 2019 Phase 2 trial • 56 Patients • NCT00737893

Clavien III

100%

80%

60%

40%

20%

Study treatment Arm

Erythropoietin (EPO)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anemia Treatment BundleExperimental Treatment2 Interventions

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).

Group II: Control (Standard of Care) GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iron Dextran

2008

Completed Phase 3

~170

Erythropoietin (EPO)

2017