AnemiaPhase 2PABST-BRNCT05167734
Practical Anemia Bundle for SusTained Blood Recovery
A Phase 2 study testing Iron Dextran and Erythropoietin (EPO) in people with Anemia and Critical Illness, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Critical Illness
- What is being tested?
- Iron Dextran and Erythropoietin (EPO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 26 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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).
Read the 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.
- Conditions
- Anemia, Critical Illness
- Being tested
- Iron Dextran, Erythropoietin (EPO)
- Medical subject headings
- Anemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron DextranDrug
1000 mg IV
Erythropoietin (EPO)Drug
Also called EPO
40,000 units subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Control (Standard of Care) Group | No intervention | Subjects will receive standard clinical care for the treatment of anemia while in the ICU. |
| Anemia Treatment Bundle | Experimental | 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). Receives: Drug: Iron Dextran; Drug: Erythropoietin (EPO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Concentrations
Hemoglobin is a protein that cares oxygen through the body
Measured: 1 month post-hospitalization
Secondary outcomes (16)
Hemoglobin Concentrations
Hemoglobin is a protein that cares oxygen through the body
Measured: Hospital discharge (approximately 1 month), 3 months post-hospitalization
Phlebotomy Practice-Blood Draws
Number of times subjects have blood drawn
Measured: Hospital discharge (approximately 1 month)
Phlebotomy Practice-Volume
Total volume of phlebotomy blood draws
Measured: Hospital discharge (approximately 1 month)
Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)
The EuroQol (EQ-5D) is a 5-item questionnaire that assess health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total score ranges from 0 to 100, with higher scores indicating improved health.
Measured: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. Each question is rated on a 4-point scale where 0 represents "very much" fatigued and 4 represents "not at all" fatigued. Total scores range from 0 to 52 with lower scores indicating greater fatigue.
Measured: 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.
Measured: 1 and 3-months post-hospitalization
Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)
The Montreal Cognitive Assessment (MoCA-BLIND) score assesses cognitive impairment by a 30-item questionnaire that includes tests of orientation, attention, memory, language and visual-spatial skills. Possible scores range from 0 to 30, with higher scores indicating higher cognitive function. A final total score of 26 and above is considered normal.
Measured: 1 and 3-months post-hospitalization
Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) assesses a patient's anxiety and depression levels. Subject's answer 14 questions (7 for anxiety and 7 for depression). Each question is scored from 0-3. Total scores can range from 0 to 21 for either anxiety or depression, with higher scores indicating a presence of anxiety or depression.
Measured: 1 and 3-months post-hospitalization
Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)
The Impact of Events Scale-Revised (IES-R) is a self-reported questionnaire that measures the distress caused by traumatic events. Subjects respond to 22 questions using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 88, with a higher score indicting the likely presence of post-traumatic stress disorder (PTSD).
Measured: 1 and 3-months post-hospitalization
Number of Participants With Allogeneic Red Blood Cell Transfusions
Number (percentage) of patients transfused with allogeneic red blood cells
Measured: 3-months post-hospitalization
Number of Transfused Units of Allogeneic Red Blood Cells
Number of transfused units from hospital discharge through 3-months post-hospitalization
Measured: 3 months post hospitalization
Unplanned Hospital Readmissions
Number of subjects to experience an unplanned hospital readmission
Measured: 3 months and 12-months post-hospitalization
Mortality
Mortality from any cause
Measured: 3 months and 12-months post-hospitalization
Adverse Events Post-enrollment
Venous thromboembolism, bloodstream infection, myocardial infarction, stroke
Measured: Hospital discharge (approximately 1 month), 3-months post-hospitalization
Accelerometry-measured Number of Steps Taken Per Day
Home-based activity monitor daily step counts (optional, exploratory study component)
Measured: 1 and 3-months post-hospitalization
Accelerometry-measured Daily Maximum Step Cadence
Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint)
Measured: 1 month and 3 month post hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start30 Nov 2021
- Primary completion4 Mar 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Matthew A. Warner, Mayo Clinic
- Investigators
- Matthew Warner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167734
- Sponsor's protocol ID
- 21-006511
- Other IDs
- K23HL153310-01
- Acronym
- PABST-BR
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2021
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Fortune E, Hanson AC, Faust L, Johnson ML, Anderson BK, Flaby GW, Schulte PJ, Cheville AL, Gajic O, Warner MA. Feasibility of Activity Monitors to Assess Physical Capacity After Critical Illness: An Observational Study Nested Within a Randomized Clinical Trial. Mayo Clin Proc Digit Health. 2026 Jul 10;4(3):100388. doi: 10.1016/j.mcpdig.2026.100388. eCollection 2026 Sep.
PubMed 42603965Warner MA, Johnson ML, Hanson AC, Fortune E, Flaby GW, Schulte PJ, Hazelton VM, Go RS, Beam WB, Charnin JE, Anderson BK, Karon B, Cheville AL, Gajic O, Kor DJ. Practical Anemia Bundle and Hemoglobin Recovery in Critical Illness: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e252353. doi: 10.1001/jamanetworkopen.2025.2353.
PubMed 40152861Warner MA, Go RS, Schulte PJ, Beam WB, Charnin JE, Meade L, Droege KA, Anderson BK, Johnson ML, Karon B, Cheville A, Gajic O, Kor DJ. Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial. BMJ Open. 2022 Dec 2;12(12):e064017. doi: 10.1136/bmjopen-2022-064017.
PubMed 36460332
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial
- ClinicalTrials.gov ID
- NCT05167734
- Acronym / sponsor ID
- PABST-BR / 21-006511
- Conditions
- Anemia, Critical Illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Standard of Care) Group | No intervention | –Subjects will receive standard clinical care for the treatment of anemia while in the ICU. |
| Anemia Treatment Bundle | Experimental | Drug: Iron Dextran, Drug: Erythropoietin (EPO)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Dextran1000 mg IV | Drug | Anemia Treatment Bundle |
| Erythropoietin (EPO)Also: EPO40,000 units subcutaneous | Drug | Anemia Treatment Bundle |
Primary outcome
Hemoglobin Concentrations
Time frame: 1 month post-hospitalization
Hemoglobin is a protein that cares oxygen through the body
16 secondary outcomes
Hemoglobin Concentrations
Time frame: Hospital discharge (approximately 1 month), 3 months post-hospitalization
Phlebotomy Practice-Blood Draws
Time frame: Hospital discharge (approximately 1 month)
Phlebotomy Practice-Volume
Time frame: Hospital discharge (approximately 1 month)
Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)
Time frame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time frame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
6 Minute Walk Distance
Time frame: 1 and 3-months post-hospitalization
Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)
Time frame: 1 and 3-months post-hospitalization
Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS)
Time frame: 1 and 3-months post-hospitalization
Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)
Time frame: 1 and 3-months post-hospitalization
Number of Participants With Allogeneic Red Blood Cell Transfusions
Time frame: 3-months post-hospitalization
Number of Transfused Units of Allogeneic Red Blood Cells
Time frame: 3 months post hospitalization
Unplanned Hospital Readmissions
Time frame: 3 months and 12-months post-hospitalization
Mortality
Time frame: 3 months and 12-months post-hospitalization
Adverse Events Post-enrollment
Time frame: Hospital discharge (approximately 1 month), 3-months post-hospitalization
Accelerometry-measured Number of Steps Taken Per Day
Time frame: 1 and 3-months post-hospitalization
Accelerometry-measured Daily Maximum Step Cadence
Time frame: 1 month and 3 month post hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42603965Fortune E, Hanson AC, Faust L, Johnson ML, Anderson BK, Flaby GW, Schulte PJ, Cheville AL, Gajic O, Warner MA. Feasibility of Activity Monitors to Assess Physical Capacity After Critical Illness: An Observational Study Nested Within a Randomized Clinical Trial. Mayo Clin Proc Digit Health. 2026 Jul 10;4(3):100388. doi: 10.1016/j.mcpdig.2026.100388. eCollection 2026 Sep.
- Derived from this study: PubMed 40152861Warner MA, Johnson ML, Hanson AC, Fortune E, Flaby GW, Schulte PJ, Hazelton VM, Go RS, Beam WB, Charnin JE, Anderson BK, Karon B, Cheville AL, Gajic O, Kor DJ. Practical Anemia Bundle and Hemoglobin Recovery in Critical Illness: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e252353. doi: 10.1001/jamanetworkopen.2025.2353.
- Derived from this study: PubMed 36460332Warner MA, Go RS, Schulte PJ, Beam WB, Charnin JE, Meade L, Droege KA, Anderson BK, Johnson ML, Karon B, Cheville A, Gajic O, Kor DJ. Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial. BMJ Open. 2022 Dec 2;12(12):e064017. doi: 10.1136/bmjopen-2022-064017.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Warner, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iron Dextran and Erythropoietin (EPO) in people with Anemia and Critical Illness, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin Concentrations (time frame: 1 month post-hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167734, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.