Anemia, Critical Illness
Conditions
Brief 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).
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.
Interventions
DRUGIron Dextran
1000 mg IV
40,000 units subcutaneous
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Concentrations | 1 month post-hospitalization | Hemoglobin is a protein that cares oxygen through the body |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phlebotomy Practice-Blood Draws | Hospital discharge (approximately 1 month) | Number of times subjects have blood drawn |
| Phlebotomy Practice-Volume | Hospital discharge (approximately 1 month) | Total volume of phlebotomy blood draws |
| 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. |
| 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. |
| 6 Minute Walk Distance | 1 and 3-months post-hospitalization | Distance walked in 6 minutes used to assess physical function after critical illness. |
| 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. |
| 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. |
| Hemoglobin Concentrations | Hospital discharge (approximately 1 month), 3 months post-hospitalization | Hemoglobin is a protein that cares oxygen through the body |
| Number of Participants With Allogeneic Red Blood Cell Transfusions | 3-months post-hospitalization | Number (percentage) of patients transfused with allogeneic red blood cells |
| Number of Transfused Units of Allogeneic Red Blood Cells | 3 months post hospitalization | Number of transfused units from hospital discharge through 3-months post-hospitalization |
| Unplanned Hospital Readmissions | 3 months and 12-months post-hospitalization | Number of subjects to experience an unplanned hospital readmission |
| Mortality | 3 months and 12-months post-hospitalization | Mortality from any cause |
| Adverse Events Post-enrollment | Hospital discharge (approximately 1 month), 3-months post-hospitalization | Venous thromboembolism, bloodstream infection, myocardial infarction, stroke |
| Accelerometry-measured Number of Steps Taken Per Day | 1 and 3-months post-hospitalization | Home-based activity monitor daily step counts (optional, exploratory study component) |
| Accelerometry-measured Daily Maximum Step Cadence | 1 month and 3 month post hospitalization | Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint) |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control (Standard of Care) Group Subjects received standard clinical care for the treatment of anemia while in the ICU. | 51 |
| Anemia Treatment Bundle 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).
Iron Dextran: 1000 mg IV
Erythropoietin (EPO): 40,000 units subcutaneous | 49 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control (Standard of Care) Group | Total | Anemia Treatment Bundle |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 11.6 | 65.6 years STANDARD_DEVIATION 10.5 | 65.4 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 98 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 50 Participants | 98 Participants | 48 Participants |
| Region of Enrollment United States | 51 participants | 100 participants | 49 participants |
| Sex: Female, Male Female | 23 Participants | 43 Participants | 20 Participants |
| Sex: Female, Male Male | 28 Participants | 57 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 51 | 3 / 49 |
| other Total, other adverse events | 5 / 51 | 4 / 49 |
| serious Total, serious adverse events | 3 / 51 | 1 / 49 |
Outcome results
Primary
Hemoglobin Concentrations
Hemoglobin is a protein that cares oxygen through the body
Time frame: 1 month post-hospitalization
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (Standard of Care) Group | Hemoglobin Concentrations | 11.5 g/dL |
| Anemia Treatment Bundle | Hemoglobin Concentrations | 12.2 g/dL |
p-value: 0.0295% CI: [0.1, 1.2]Mixed Models Analysis
Secondary
6 Minute Walk Distance
Distance walked in 6 minutes used to assess physical function after critical illness.
Time frame: 1 and 3-months post-hospitalization
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | 6 Minute Walk Distance | 1 month post hospitalization | 1080 Feet |
| Control (Standard of Care) Group | 6 Minute Walk Distance | 3 months post hospitalization | 1208 Feet |
| Anemia Treatment Bundle | 6 Minute Walk Distance | 1 month post hospitalization | 1211 Feet |
| Anemia Treatment Bundle | 6 Minute Walk Distance | 3 months post hospitalization | 1220 Feet |
Comparison: 1-month post hospitalizationp-value: 0.1395% CI: [-73, 510]Mixed Models Analysis
Comparison: 3-months post hospitalizationp-value: 0.2795% CI: [-154, 510]Mixed Models Analysis
Secondary
Accelerometry-measured Daily Maximum Step Cadence
Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint)
Time frame: 1 month and 3 month post hospitalization
Population: No data was collected or analyzed for 33 participants in the control standard of care arm and 27 participants in the anemia treatment bundle arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Accelerometry-measured Daily Maximum Step Cadence | 1 month post hospitalization | 67.0 Steps per Minute |
| Control (Standard of Care) Group | Accelerometry-measured Daily Maximum Step Cadence | 3 months post hospitalization | 71.1 Steps per Minute |
| Anemia Treatment Bundle | Accelerometry-measured Daily Maximum Step Cadence | 1 month post hospitalization | 64.4 Steps per Minute |
| Anemia Treatment Bundle | Accelerometry-measured Daily Maximum Step Cadence | 3 months post hospitalization | 61.4 Steps per Minute |
Secondary
Accelerometry-measured Number of Steps Taken Per Day
Home-based activity monitor daily step counts (optional, exploratory study component)
Time frame: 1 and 3-months post-hospitalization
Population: No data was collected or analyzed for 33 participants in the control standard of care arm and 27 participants in the anemia treatment bundle arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Accelerometry-measured Number of Steps Taken Per Day | 1 month post hospitalization | 6481 Number of steps per day |
| Control (Standard of Care) Group | Accelerometry-measured Number of Steps Taken Per Day | 3 month post hospitalization | 8281 Number of steps per day |
| Anemia Treatment Bundle | Accelerometry-measured Number of Steps Taken Per Day | 1 month post hospitalization | 6017 Number of steps per day |
| Anemia Treatment Bundle | Accelerometry-measured Number of Steps Taken Per Day | 3 month post hospitalization | 6874 Number of steps per day |
Secondary
Adverse Events Post-enrollment
Venous thromboembolism, bloodstream infection, myocardial infarction, stroke
Time frame: Hospital discharge (approximately 1 month), 3-months post-hospitalization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (Standard of Care) Group | Adverse Events Post-enrollment | Venous Thromboembolism | 4 Participants |
| Control (Standard of Care) Group | Adverse Events Post-enrollment | Myocardial Infarction | 2 Participants |
| Control (Standard of Care) Group | Adverse Events Post-enrollment | Stroke | 0 Participants |
| Control (Standard of Care) Group | Adverse Events Post-enrollment | Bloodstream Infection | 2 Participants |
| Anemia Treatment Bundle | Adverse Events Post-enrollment | Myocardial Infarction | 1 Participants |
| Anemia Treatment Bundle | Adverse Events Post-enrollment | Venous Thromboembolism | 2 Participants |
| Anemia Treatment Bundle | Adverse Events Post-enrollment | Bloodstream Infection | 0 Participants |
| Anemia Treatment Bundle | Adverse Events Post-enrollment | Stroke | 2 Participants |
Secondary
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.
Time frame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Hosptial Discharge | 28 score on a scale |
| Control (Standard of Care) Group | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | 1 month post hospitalization | 37 score on a scale |
| Control (Standard of Care) Group | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | 3 months post hospitalization | 44 score on a scale |
| Anemia Treatment Bundle | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Hosptial Discharge | 32 score on a scale |
| Anemia Treatment Bundle | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | 1 month post hospitalization | 41 score on a scale |
| Anemia Treatment Bundle | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | 3 months post hospitalization | 46 score on a scale |
Comparison: Hospital dischargep-value: 0.2395% CI: [0.68, 4.8]proportional odds
Comparison: 1-month post hospitalizationp-value: 0.0995% CI: [0.87, 6.8]proportional odds
Comparison: 3-months post hospitalizationp-value: 0.08495% CI: [0.88, 7.2]proportional odds
Secondary
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.
Time frame: 1 and 3-months post-hospitalization
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | 1 month post hospitalization | 19 score on a scale |
| Control (Standard of Care) Group | Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | 3 months post hospitalization | 20 score on a scale |
| Anemia Treatment Bundle | Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | 1 month post hospitalization | 20 score on a scale |
| Anemia Treatment Bundle | Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | 3 months post hospitalization | 21 score on a scale |
Comparison: 1-month post hospitalizationp-value: 0.1295% CI: [0.79, 7.8]proportional odds
Comparison: 3-months post hospitalizationp-value: 0.0795% CI: [0.91, 10.5]proportional odds
Secondary
Hemoglobin Concentrations
Hemoglobin is a protein that cares oxygen through the body
Time frame: Hospital discharge (approximately 1 month), 3 months post-hospitalization
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Hemoglobin Concentrations | Hospital discharge | 9.0 g/dL |
| Control (Standard of Care) Group | Hemoglobin Concentrations | 3-months post hospitalization | 12.8 g/dL |
| Anemia Treatment Bundle | Hemoglobin Concentrations | Hospital discharge | 9.6 g/dL |
| Anemia Treatment Bundle | Hemoglobin Concentrations | 3-months post hospitalization | 13.4 g/dL |
Comparison: 3-months post hospitalizationp-value: 0.0495% CI: [0, 1.1]Mixed Models Analysis
Comparison: Hospital Dischargep-value: 0.4295% CI: [-0.3, 0.7]Mixed Models Analysis
Secondary
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.
Time frame: 1 and 3-months post-hospitalization
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Anxiety Score-1 month post hospitalization | 2 score on a scale |
| Control (Standard of Care) Group | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Anxiety Score-3 months post hospitalization | 1 score on a scale |
| Control (Standard of Care) Group | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Depression Score-1 month post hospitalization | 4 score on a scale |
| Control (Standard of Care) Group | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Depression Score-3 months post hospitalization | 1 score on a scale |
| Anemia Treatment Bundle | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Depression Score-3 months post hospitalization | 1 score on a scale |
| Anemia Treatment Bundle | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Anxiety Score-1 month post hospitalization | 1 score on a scale |
| Anemia Treatment Bundle | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Depression Score-1 month post hospitalization | 2 score on a scale |
| Anemia Treatment Bundle | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | Anxiety Score-3 months post hospitalization | 0 score on a scale |
Comparison: 1-month post hospitalization for anxiety scorep-value: 0.2995% CI: [0.14, 1.8]proportional odds
Comparison: 3-months post hospitalization for anxiety scorep-value: 0.5795% CI: [0.18, 2.6]proportional odds
Comparison: 1-month post hospitalization for depression scorep-value: 0.1295% CI: [0.1, 1.3]proportional odds
Comparison: 3-months post hospitalization for depression scorep-value: 0.4895% CI: [0.16, 2.4]proportional odds
Secondary
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).
Time frame: 1 and 3-months post-hospitalization
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | 1 month post hospitalization | 1 score on a scale |
| Control (Standard of Care) Group | Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | 3 months post hospitalization | 0 score on a scale |
| Anemia Treatment Bundle | Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | 1 month post hospitalization | 3 score on a scale |
| Anemia Treatment Bundle | Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | 3 months post hospitalization | 0 score on a scale |
Comparison: 1-month post hospitalizationp-value: 0.5695% CI: [0.39, 5.6]proportional odds
Comparison: 3-months post hospitalizationp-value: 0.0295% CI: [1.4, 59.9]proportional odds
Secondary
Mortality
Mortality from any cause
Time frame: 3 months and 12-months post-hospitalization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (Standard of Care) Group | Mortality | 3 months post hospitalization | 1 Participants |
| Control (Standard of Care) Group | Mortality | 12 months post hospitalization | 2 Participants |
| Anemia Treatment Bundle | Mortality | 3 months post hospitalization | 2 Participants |
| Anemia Treatment Bundle | Mortality | 12 months post hospitalization | 3 Participants |
Comparison: 3-months post hospitalizationp-value: 0.5495% CI: [0.19, 24]Regression, Logistic
Secondary
Number of Participants With Allogeneic Red Blood Cell Transfusions
Number (percentage) of patients transfused with allogeneic red blood cells
Time frame: 3-months post-hospitalization
Population: No data was collected or analyzed for 1 participant in the anemia treatment bundle arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (Standard of Care) Group | Number of Participants With Allogeneic Red Blood Cell Transfusions | 6 Participants |
| Anemia Treatment Bundle | Number of Participants With Allogeneic Red Blood Cell Transfusions | 1 Participants |
p-value: 0.0995% CI: [0.02, 1.4]Regression, Logistic
Secondary
Number of Transfused Units of Allogeneic Red Blood Cells
Number of transfused units from hospital discharge through 3-months post-hospitalization
Time frame: 3 months post hospitalization
Population: No data was collected or analyzed for 1 participant in the anemia treatment bundle arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (Standard of Care) Group | Number of Transfused Units of Allogeneic Red Blood Cells | 0 Transfused units |
| Anemia Treatment Bundle | Number of Transfused Units of Allogeneic Red Blood Cells | 0 Transfused units |
Secondary
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.
Time frame: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Standard of Care) Group | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | Hospital discharge | 60 score on a scale |
| Control (Standard of Care) Group | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | 1 month post hospitalization | 65 score on a scale |
| Control (Standard of Care) Group | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | 3 months post hospitalization | 80 score on a scale |
| Anemia Treatment Bundle | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | Hospital discharge | 51 score on a scale |
| Anemia Treatment Bundle | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | 1 month post hospitalization | 70 score on a scale |
| Anemia Treatment Bundle | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | 3 months post hospitalization | 80 score on a scale |
Comparison: Hospital Dischargep-value: 0.9495% CI: [0.44, 2.4]proportional odds
Comparison: 1-month post hospitalizationp-value: 0.1895% CI: [0.76, 4.2]proportional odds
Comparison: 3-months post hospitalizationp-value: 0.6495% CI: [0.51, 3]proportional odds
Secondary
Phlebotomy Practice-Blood Draws
Number of times subjects have blood drawn
Time frame: Hospital discharge (approximately 1 month)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (Standard of Care) Group | Phlebotomy Practice-Blood Draws | 46 Number of blood draws |
| Anemia Treatment Bundle | Phlebotomy Practice-Blood Draws | 32 Number of blood draws |
p-value: 0.352Mixed Models Analysis
Secondary
Phlebotomy Practice-Volume
Total volume of phlebotomy blood draws
Time frame: Hospital discharge (approximately 1 month)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (Standard of Care) Group | Phlebotomy Practice-Volume | 142 mL |
| Anemia Treatment Bundle | Phlebotomy Practice-Volume | 32 mL |
p-value: <0.001Mixed Models Analysis
Secondary
Unplanned Hospital Readmissions
Number of subjects to experience an unplanned hospital readmission
Time frame: 3 months and 12-months post-hospitalization
Population: No data was collected or analyzed for 1 participant in the anemia treatment bundle arm at 3-months post hospitalization. No data was collected or analyzed for 1 participant in the anemia treatment bundle arm at 12-months post hospitalization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (Standard of Care) Group | Unplanned Hospital Readmissions | 3 months post hospitalization | 16 Participants |
| Control (Standard of Care) Group | Unplanned Hospital Readmissions | 12 months post hospitalization | 30 Participants |
| Anemia Treatment Bundle | Unplanned Hospital Readmissions | 3 months post hospitalization | 12 Participants |
| Anemia Treatment Bundle | Unplanned Hospital Readmissions | 12 months post hospitalization | 24 Participants |
Comparison: 3-months post hospitalizationp-value: 0.4895% CI: [0.3, 1.8]Regression, Logistic