Trial · NCT05167734
Practical Anemia Bundle for SusTained Blood Recovery
NCT05167734, Phase 2, Completed, Mayo Clinic; results first posted 2025-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Practical Anemia Bundle for SusTained Blood Recovery. Trials, record NCT05167734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05167734
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Practical Anemia Bundle for SusTained Blood Recovery
- NCT number
- NCT05167734
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Anemia, Critical Illness
- Interventions
- Iron Dextran, Erythropoietin (EPO)
- First posted
- 2021-12-22
- Last updated
- 2025-04-06
- Results first posted
- 2025-04-06
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemoglobin Concentrations | 1 month post-hospitalization | Hemoglobin is a protein that cares oxygen through the body |
| Secondary | Hemoglobin Concentrations | Hospital discharge (approximately 1 month), 3 months post-hospitalization | Hemoglobin is a protein that cares oxygen through the body |
| Secondary | Phlebotomy Practice-Blood Draws | Hospital discharge (approximately 1 month) | Number of times subjects have blood drawn |
| Secondary | Phlebotomy Practice-Volume | Hospital discharge (approximately 1 month) | Total volume of phlebotomy blood draws |
| Secondary | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization | 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. |
| Secondary | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization | 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. |
| Secondary | 6 Minute Walk Distance | 1 and 3-months post-hospitalization | Distance walked in 6 minutes used to assess physical function after critical illness. |
| Secondary | Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | 1 and 3-months post-hospitalization | 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. |
| Secondary | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | 1 and 3-months post-hospitalization | 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. |
| Secondary | Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | 1 and 3-months post-hospitalization | 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). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hemoglobin Concentrations | 1 month post-hospitalization | Data was not collected nor analyzed for four subjects in the Control (Standard of Care) Group and eight subjects in the Anemia Treatment Bundle arm | g/dL | MEDIAN |
| SECONDARY | Hemoglobin Concentrations | Hospital discharge (approximately 1 month), 3 months post-hospitalization | Data was not collected or analyzed for 8 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at 3-months post hospitalization. | g/dL | MEDIAN |
| SECONDARY | Phlebotomy Practice-Blood Draws | Hospital discharge (approximately 1 month) | Number of blood draws | MEDIAN | |
| SECONDARY | Phlebotomy Practice-Volume | Hospital discharge (approximately 1 month) | mL | MEDIAN | |
| SECONDARY | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization | Data was not collected nor analyzed for 1 subject in the Control (Standard of Care) arm and 1 subject in the Anemia Treatment Bundle arm at hospital discharge. No data was collected or analyzed for 6 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 subjects in the control standard of care arm and 8 subjects in the anemia treatment bundle arm at 3-months post hospitalization. | score on a scale | MEDIAN |
| SECONDARY | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization | Data was not collected or analyzed for 1 subject in the Control Standard of Care arm and 1 subject in the Anemia Treatment Bundle arm at hospital discharge. No data was collected or analyzed for 6 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at the 1-month post hospitalization. No data was collected or analyzed for 10 subject in the control standard of care arm and 8 subject in the anemia treatment bundle arm at the 3-months post hospitalization. | score on a scale | MEDIAN |
| SECONDARY | 6 Minute Walk Distance | 1 and 3-months post-hospitalization | No data was collected or analyzed for 33 participants in the control standard of care arm and 32 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 39 participants in the control standard of care arm and 41 participants in the anemia treatment bundle arm at 3-months post hospitalization. | Feet | MEDIAN |
| SECONDARY | Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | 1 and 3-months post-hospitalization | No data was collected or analyzed for 11 participants in the control standard of care arm and 10 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 14 participants in the control standard of care arm and 13 participants in the in the anemia treatment bundle arm at 3-months post hospitalization. | score on a scale | MEDIAN |
| SECONDARY | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | 1 and 3-months post-hospitalization | No data was collected or analyzed for 6 participants in the control standard of care arm and 7 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 participants in the control standard of care arm and 8 in the anemia treatment bundle arm at 3-months post hospitalization. | score on a scale | MEDIAN |
| SECONDARY | Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | 1 and 3-months post-hospitalization | No data was collected or analyzed for 6 participants in the control standard of care arm and 7 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 participants in the control standard of care arm and 8 in the anemia treatment bundle arm at 3-months post hospitalization. | score on a scale | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hemoglobin Concentrations | Control (Standard of Care) Group | 11.5 | Inter-Quartile Range 10.3 to 12.6 | g/dL | |
| Hemoglobin Concentrations | Anemia Treatment Bundle | 12.2 | Inter-Quartile Range 11.8 to 13.0 | g/dL | |
| Hemoglobin Concentrations | Control (Standard of Care) Group | Hospital discharge | 9.0 | Inter-Quartile Range 8.6 to 10.0 | g/dL |
| Hemoglobin Concentrations | Anemia Treatment Bundle | Hospital discharge | 9.6 | Inter-Quartile Range 8.9 to 9.9 | g/dL |
| Hemoglobin Concentrations | Control (Standard of Care) Group | 3-months post hospitalization | 12.8 | Inter-Quartile Range 11.7 to 13.8 | g/dL |
| Hemoglobin Concentrations | Anemia Treatment Bundle | 3-months post hospitalization | 13.4 | Inter-Quartile Range 12.2 to 14.6 | g/dL |
| Phlebotomy Practice-Blood Draws | Control (Standard of Care) Group | 46 | Inter-Quartile Range 20 to 74 | Number of blood draws | |
| Phlebotomy Practice-Blood Draws | Anemia Treatment Bundle | 32 | Inter-Quartile Range 24 to 55 | Number of blood draws | |
| Phlebotomy Practice-Volume | Control (Standard of Care) Group | 142 | Inter-Quartile Range 68 to 195 | mL | |
| Phlebotomy Practice-Volume | Anemia Treatment Bundle | 32 | Inter-Quartile Range 22 to 54 | mL |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control (Standard of Care) Group | 51 | |
| Overall Study | STARTED | Anemia Treatment Bundle | 49 | |
| Overall Study | COMPLETED | Control (Standard of Care) Group | 51 | |
| Overall Study | COMPLETED | Anemia Treatment Bundle | 49 | |
| Overall Study | NOT COMPLETED | Control (Standard of Care) Group | 0 | |
| Overall Study | NOT COMPLETED | Anemia Treatment Bundle | 0 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Venous thromboembolism | Vascular disorders | Control (Standard of Care) Group | 4 | 51 | 4 |
| other | Venous thromboembolism | Vascular disorders | Anemia Treatment Bundle | 2 | 49 | 2 |
| other | Myocardial ischemia | Cardiac disorders | Control (Standard of Care) Group | 1 | 51 | 1 |
| other | Myocardial ischemia | Cardiac disorders | Anemia Treatment Bundle | 1 | 49 | 1 |
| other | Stroke | Vascular disorders | Control (Standard of Care) Group | 0 | 51 | 0 |
| other | Stroke | Vascular disorders | Anemia Treatment Bundle | 1 | 49 | 1 |
| serious | Bloodstream Infection | Blood and lymphatic system disorders | Control (Standard of Care) Group | 2 | 51 | 2 |
| serious | Bloodstream Infection | Blood and lymphatic system disorders | Anemia Treatment Bundle | 0 | 49 | 0 |
| serious | Myocardial Infarction | Cardiac disorders | Control (Standard of Care) Group | 1 | 51 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | Anemia Treatment Bundle | 0 | 49 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control (Standard of Care) Group | 2 | 51 |
| Total, all-cause mortality | Anemia Treatment Bundle | 3 | 49 |
| Total, other adverse events | Control (Standard of Care) Group | 5 | 51 |
| Total, other adverse events | Anemia Treatment Bundle | 4 | 49 |
| Total, serious adverse events | Control (Standard of Care) Group | 3 | 51 |
| Total, serious adverse events | Anemia Treatment Bundle | 1 | 49 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23HL153310 | Attenuation of Anemia for the Optimization of Post-Hospitalization Functional Recovery in Survivors of Critical Illness | WARNER, MATTHEW A | MAYO CLINIC ROCHESTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2021 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anemia Treatment Bundle vs Control (Standard of Care) Group: Number of Participants With Allogeneic Red Blood Cell Transfusions | Trial comparisons |
| Anemia Treatment Bundle vs Control (Standard of Care) Group: deaths from any cause | Trial comparisons |
| Anemia Treatment Bundle vs Control (Standard of Care) Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05167734
GET https://conductscience.org/api/trials/v1/NCT05167734/results?page=2