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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
Awards & highlights
PABST-BR Trial 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.Check my eligibility
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.See study design
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.
PABST-BR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hemoglobin level is below 10 g/dL, and I have moderate-to-severe anemia.
Select...
I have been in the ICU for less than 7 days.
PABST-BR Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
6 minute walk distance
Actigraph activity expenditures
Adverse events post-enrollment
+10 moreSide effects data
From 2019 Phase 2 trial • 56 Patients • NCT007378933%
Clavien III
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erythropoietin (EPO)
Placebo
PABST-BR 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
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,494 Total Patients Enrolled
101 Trials studying Anemia
18,194 Patients Enrolled for Anemia
Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,938 Total Patients Enrolled
7 Trials studying Anemia
2,793 Patients Enrolled for Anemia
Matthew Warner, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
78 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received 10 or more blood transfusions in the last 2 days.My hemoglobin level is below 10 g/dL, and I have moderate-to-severe anemia.I weigh less than 40 kg.I have been in the ICU for less than 7 days.I or my legal proxy have signed the consent form.I am able to attend follow-up appointments and complete assessments.I have an infection that hasn't been controlled with treatment in the last 2 days.I have not had a blood clot in the past 3 months.I have had a heart attack or stroke in the last 3 months.I can't take blood clot prevention medication due to recent surgery or GI bleeding.I have not used IV iron or blood cell production boosters in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Control (Standard of Care) Group
- Group 2: Anemia Treatment Bundle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for people to enroll in this research project?
"The study, which as of 4/25/2022 is still recruiting patients, was first posted on clinicaltrials.gov on 11/30/2021."
Answered by AI
Could you explain the risks associated with Erythropoietin (EPO) treatments?
"Erythropoietin (EPO) has received a score of 2 for safety. This is based on it being a Phase 2 trial, where there is data supporting safety but not efficacy."
Answered by AI
How many people can sign up for this experiment at most?
"The clinical trial is still recruiting patients, according to the most recent information available on clinicaltrials.gov. This study was posted on November 30th, 2021 and edited April 25th, 2022. They are 1 site down 100 patients."
Answered by AI
How has Erythropoietin been shown to help patients in the past?
"Erythropoietin (EPO) is most often used when there is a high risk of blood loss. However, it can also be given to patients experiencing blood loss from surgery or chemotherapy, and those with hiv."
Answered by AI
Does EPO have a long and successful history of being studied?
"Erythropoietin (EPO) is being trialed in 24 different studies, 8 of which are in the third and final stage. Most of the EPO trials are taking place in Palma de Mallorca, Islas Baleares, but there are 1113 total locations running clinical trials for this medication."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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