Practical Anemia Bundle for SusTained Blood Recovery

Anemia Clinical Trial

— PABST-BR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05167734
• Other study ID #: 21-006511
• Secondary ID: K23HL153310-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 30, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Critical Illness

Intervention

Drug:
• Iron Dextran
1000 mg IV
• Erythropoietin (EPO)
40,000 units subcutaneous

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin concentrations	Mean difference in hemoglobin concentrations	1 month post-hospitalization
Secondary	Hemoglobin concentrations	Mean difference in hemoglobin concentrations	Hospital discharge (approximately 1 month) and 3 months post-hospitalization
Secondary	Phlebotomy practice	Number of times subjects have blood drawn and total phlebotomy volumes	Hospital discharge (approximately 1 month)
Secondary	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
Secondary	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
Secondary	6 minute walk distance	Distance walked in 6 minutes used to assess physical function after critical illness.	1 and 3-months post-hospitalization
Secondary	Cognitive function after critical illness	Montreal Cognitive Assessment (MoCA-BLIND)	1 and 3-months post-hospitalization
Secondary	Mental Health - Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS)	1 and 3-months post-hospitalization
Secondary	Mental Health - Post-Traumatic Distress	Impact of Events Scale-Revised (IES-R)	1 and 3-months post-hospitalization
Secondary	Allogeneic red blood cell transfusions	Proportion of patients transfused and number of transfused units	Hospital discharge (approximately 1 month) and 3-months post-hospitalization
Secondary	Unplanned hospital readmissions	Number of subjects to experience an unplanned hospital readmission	12-months post-hospitalization
Secondary	Mortality	Mortality from any cause	12-months post-hospitalization
Secondary	Adverse events post-enrollment	Venous thromboembolism, bloodstream infection, myocardial infarction, stroke	Hospital discharge (approximately 1 month) and 3-months post-hospitalization
Secondary	Actigraph activity expenditures	Actigraph activity monitor step counts and energy expenditure	1 and 3-months post-hospitalization

External Links

•   Mayo Clinic Clinical Trials