Trial Outcomes & Findings for Practical Anemia Bundle for SusTained Blood Recovery (NCT NCT05167734)
NCT ID: NCT05167734
Last Updated: 2025-04-06
Results Overview
Hemoglobin is a protein that cares oxygen through the body
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
1 month post-hospitalization
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Control (Standard of Care) Group
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
|
Overall Study
COMPLETED
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Practical Anemia Bundle for SusTained Blood Recovery
Baseline characteristics by cohort
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 Participants
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
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
49 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month post-hospitalizationPopulation: 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
Hemoglobin is a protein that cares oxygen through the body
Outcome measures
| Measure |
Control (Standard of Care) Group
n=47 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=41 Participants
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
|
|---|---|---|
|
Hemoglobin Concentrations
|
11.5 g/dL
Interval 10.3 to 12.6
|
12.2 g/dL
Interval 11.8 to 13.0
|
SECONDARY outcome
Timeframe: Hospital discharge (approximately 1 month), 3 months post-hospitalizationPopulation: 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.
Hemoglobin is a protein that cares oxygen through the body
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 Participants
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
|
|---|---|---|
|
Hemoglobin Concentrations
Hospital discharge
|
9.0 g/dL
Interval 8.6 to 10.0
|
9.6 g/dL
Interval 8.9 to 9.9
|
|
Hemoglobin Concentrations
3-months post hospitalization
|
12.8 g/dL
Interval 11.7 to 13.8
|
13.4 g/dL
Interval 12.2 to 14.6
|
SECONDARY outcome
Timeframe: Hospital discharge (approximately 1 month)Number of times subjects have blood drawn
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 Participants
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
|
|---|---|---|
|
Phlebotomy Practice-Blood Draws
|
46 Number of blood draws
Interval 20.0 to 74.0
|
32 Number of blood draws
Interval 24.0 to 55.0
|
SECONDARY outcome
Timeframe: Hospital discharge (approximately 1 month)Total volume of phlebotomy blood draws
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 Participants
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
|
|---|---|---|
|
Phlebotomy Practice-Volume
|
142 mL
Interval 68.0 to 195.0
|
32 mL
Interval 22.0 to 54.0
|
SECONDARY outcome
Timeframe: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalizationPopulation: 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.
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.
Outcome measures
| Measure |
Control (Standard of Care) Group
n=50 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=48 Participants
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
|
|---|---|---|
|
Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)
Hospital discharge
|
60 score on a scale
Interval 40.0 to 70.0
|
51 score on a scale
Interval 40.0 to 75.0
|
|
Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)
1 month post hospitalization
|
65 score on a scale
Interval 50.0 to 75.0
|
70 score on a scale
Interval 65.0 to 80.0
|
|
Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)
3 months post hospitalization
|
80 score on a scale
Interval 75.0 to 85.0
|
80 score on a scale
Interval 75.0 to 90.0
|
SECONDARY outcome
Timeframe: Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalizationPopulation: 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.
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.
Outcome measures
| Measure |
Control (Standard of Care) Group
n=50 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=48 Participants
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
|
|---|---|---|
|
Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Hosptial Discharge
|
28 score on a scale
Interval 19.0 to 36.0
|
32 score on a scale
Interval 24.0 to 37.0
|
|
Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
1 month post hospitalization
|
37 score on a scale
Interval 25.0 to 43.0
|
41 score on a scale
Interval 32.0 to 45.0
|
|
Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
3 months post hospitalization
|
44 score on a scale
Interval 40.0 to 46.0
|
46 score on a scale
Interval 41.0 to 48.0
|
SECONDARY outcome
Timeframe: 1 and 3-months post-hospitalizationPopulation: 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.
Distance walked in 6 minutes used to assess physical function after critical illness.
Outcome measures
| Measure |
Control (Standard of Care) Group
n=18 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=17 Participants
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
|
|---|---|---|
|
6 Minute Walk Distance
3 months post hospitalization
|
1208 Feet
Interval 880.0 to 1733.0
|
1220 Feet
Interval 1040.0 to 1683.0
|
|
6 Minute Walk Distance
1 month post hospitalization
|
1080 Feet
Interval 790.0 to 1250.0
|
1211 Feet
Interval 960.0 to 1480.0
|
SECONDARY outcome
Timeframe: 1 and 3-months post-hospitalizationPopulation: 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.
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.
Outcome measures
| Measure |
Control (Standard of Care) Group
n=40 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=39 Participants
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
|
|---|---|---|
|
Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)
1 month post hospitalization
|
19 score on a scale
Interval 18.0 to 21.0
|
20 score on a scale
Interval 19.0 to 22.0
|
|
Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)
3 months post hospitalization
|
20 score on a scale
Interval 20.0 to 21.0
|
21 score on a scale
Interval 20.0 to 22.0
|
SECONDARY outcome
Timeframe: 1 and 3-months post-hospitalizationPopulation: 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.
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.
Outcome measures
| Measure |
Control (Standard of Care) Group
n=45 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=42 Participants
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
|
|---|---|---|
|
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
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 5.0
|
|
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
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 3.0
|
|
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
Interval 1.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
|
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
Interval 1.0 to 7.0
|
2 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 1 and 3-months post-hospitalizationPopulation: 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.
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).
Outcome measures
| Measure |
Control (Standard of Care) Group
n=45 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=42 Participants
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
|
|---|---|---|
|
Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)
1 month post hospitalization
|
1 score on a scale
Interval 0.0 to 9.0
|
3 score on a scale
Interval 0.0 to 11.0
|
|
Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)
3 months post hospitalization
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 3-months post-hospitalizationPopulation: No data was collected or analyzed for 1 participant in the anemia treatment bundle arm.
Number (percentage) of patients transfused with allogeneic red blood cells
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=48 Participants
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
|
|---|---|---|
|
Number of Participants With Allogeneic Red Blood Cell Transfusions
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months post hospitalizationPopulation: No data was collected or analyzed for 1 participant in the anemia treatment bundle arm.
Number of transfused units from hospital discharge through 3-months post-hospitalization
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=48 Participants
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
|
|---|---|---|
|
Number of Transfused Units of Allogeneic Red Blood Cells
|
0 Transfused units
Interval 0.0 to 0.0
|
0 Transfused units
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 3 months and 12-months post-hospitalizationPopulation: 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.
Number of subjects to experience an unplanned hospital readmission
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=48 Participants
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
|
|---|---|---|
|
Unplanned Hospital Readmissions
3 months post hospitalization
|
16 Participants
|
12 Participants
|
|
Unplanned Hospital Readmissions
12 months post hospitalization
|
30 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 3 months and 12-months post-hospitalizationMortality from any cause
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 Participants
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
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|---|---|---|
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Mortality
3 months post hospitalization
|
1 Participants
|
2 Participants
|
|
Mortality
12 months post hospitalization
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (approximately 1 month), 3-months post-hospitalizationVenous thromboembolism, bloodstream infection, myocardial infarction, stroke
Outcome measures
| Measure |
Control (Standard of Care) Group
n=51 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 Participants
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
|
|---|---|---|
|
Adverse Events Post-enrollment
Venous Thromboembolism
|
4 Participants
|
2 Participants
|
|
Adverse Events Post-enrollment
Bloodstream Infection
|
2 Participants
|
0 Participants
|
|
Adverse Events Post-enrollment
Myocardial Infarction
|
2 Participants
|
1 Participants
|
|
Adverse Events Post-enrollment
Stroke
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 and 3-months post-hospitalizationPopulation: 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.
Home-based activity monitor daily step counts (optional, exploratory study component)
Outcome measures
| Measure |
Control (Standard of Care) Group
n=18 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=22 Participants
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
|
|---|---|---|
|
Accelerometry-measured Number of Steps Taken Per Day
1 month post hospitalization
|
6481 Number of steps per day
Interval 2690.0 to 14772.0
|
6017 Number of steps per day
Interval 3046.0 to 9010.0
|
|
Accelerometry-measured Number of Steps Taken Per Day
3 month post hospitalization
|
8281 Number of steps per day
Interval 2535.0 to 13816.0
|
6874 Number of steps per day
Interval 2275.0 to 11972.0
|
SECONDARY outcome
Timeframe: 1 month and 3 month post hospitalizationPopulation: 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.
Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint)
Outcome measures
| Measure |
Control (Standard of Care) Group
n=18 Participants
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=22 Participants
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
|
|---|---|---|
|
Accelerometry-measured Daily Maximum Step Cadence
3 months post hospitalization
|
71.1 Steps per Minute
Interval 34.3 to 106.3
|
61.4 Steps per Minute
Interval 29.5 to 110.7
|
|
Accelerometry-measured Daily Maximum Step Cadence
1 month post hospitalization
|
67.0 Steps per Minute
Interval 27.0 to 102.5
|
64.4 Steps per Minute
Interval 29.8 to 109.5
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Adverse Events
Control (Standard of Care) Group
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Anemia Treatment Bundle
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Control (Standard of Care) Group
n=51 participants at risk
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Bloodstream Infection
|
3.9%
2/51 • Number of events 2 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
0.00%
0/49 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
|
Cardiac disorders
Myocardial Infarction
|
2.0%
1/51 • Number of events 1 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
0.00%
0/49 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
|
Vascular disorders
Stroke
|
0.00%
0/51 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
|
Vascular disorders
Venous Thromboembolism
|
0.00%
0/51 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
0.00%
0/49 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
Other adverse events
| Measure |
Control (Standard of Care) Group
n=51 participants at risk
Subjects received standard clinical care for the treatment of anemia while in the ICU.
|
Anemia Treatment Bundle
n=49 participants at risk
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
|
|---|---|---|
|
Vascular disorders
Venous thromboembolism
|
7.8%
4/51 • Number of events 4 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
4.1%
2/49 • Number of events 2 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
|
Cardiac disorders
Myocardial ischemia
|
2.0%
1/51 • Number of events 1 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
|
Vascular disorders
Stroke
|
0.00%
0/51 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place