Trial Outcomes & Findings for Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery (NCT NCT02189889)
NCT ID: NCT02189889
Last Updated: 2020-10-23
Results Overview
Successful adherence is defined as adhering to dosing in ≥90% of patients for ≥90% of the doses deemed appropriate by the surveillance strategy.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Preoperative 1st dose through Postoperative Day (POD) 2.
Results posted on
2020-10-23
Participant Flow
Participant milestones
| Measure |
EPO and Feraheme
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EPO and Feraheme
n=2 Participants
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
n=3 Participants
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Preoperative 1st dose through Postoperative Day (POD) 2.Successful adherence is defined as adhering to dosing in ≥90% of patients for ≥90% of the doses deemed appropriate by the surveillance strategy.
Outcome measures
| Measure |
EPO and Feraheme
n=2 Participants
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
n=3 Participants
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
|---|---|---|
|
# of Participants Who Adhered to the Study Protocol
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline hemoglobin level to day of surgery (DOS), to POD 5.Outcome measures
| Measure |
EPO and Feraheme
n=2 Participants
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
n=3 Participants
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
|---|---|---|
|
Change From Baseline Hemoglobin Level Assessed at Different Time Points Within the 2 Arms.
Baseline hemoglobin level to DOS
|
2.9 grams per deciliter (g/dl)
Standard Deviation 1.1
|
3.33 grams per deciliter (g/dl)
Standard Deviation 1.49
|
|
Change From Baseline Hemoglobin Level Assessed at Different Time Points Within the 2 Arms.
Baseline hemoglobin level to POD5
|
4.2 grams per deciliter (g/dl)
Standard Deviation 0.2
|
2.2 grams per deciliter (g/dl)
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Change from Baseline reticulocyte count to DOS, to POD 5.Population: Data were not collected for intervention group
Outcome measures
| Measure |
EPO and Feraheme
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
n=3 Participants
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
|---|---|---|
|
Change From Baseline Reticulocyte Count Assessed at Different Time Points Within the 2 Arms.
Baseline reticulocyte count to DOS
|
—
|
0.43 cells × 10^9/L
Standard Deviation 0.48
|
|
Change From Baseline Reticulocyte Count Assessed at Different Time Points Within the 2 Arms.
Baseline reticulocyte count to POD5
|
—
|
1.35 cells × 10^9/L
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Preoperative 1st dose through 30 days following surgery.Number of blood products utilized per patient receiving erythrocyte transfusions, including red blood cells, platelets and plasma.
Outcome measures
| Measure |
EPO and Feraheme
n=2 Participants
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
n=3 Participants
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
|---|---|---|
|
Number of Blood Products Utilized Per Patient Receiving Erythrocyte Transfusions.
|
2.5 blood product count
Standard Deviation 2.5
|
12.33 blood product count
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: Preoperative 1st dose through 30 days following surgery.Incidence of mortality, major cardiac, renal, neurological events (associated with anemia) and infection. These events will include myocardial infarction, prolonged low-output state, encephalopathy, duration of mechanical ventilation, renal insufficiency,mortality and dialysis dependence at 30 days.
Outcome measures
| Measure |
EPO and Feraheme
n=2 Participants
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
n=3 Participants
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
|---|---|---|
|
Incidence of Pre-defined Clinical Events in Each of the Study Arms
|
0 Participants
|
1 Participants
|
Adverse Events
EPO and Feraheme
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EPO and Feraheme
n=2 participants at risk
Patients in the treatment group will receive a subcutaneous injection of EPO 300U/kg at the Baseline visit, the Preoperative visit and on POD 2; and an infusion of Feraheme 510mg at the Baseline visit and the Preoperative visit.
EPO: The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
Feraheme: Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
|
Control
n=3 participants at risk
The control group will receive no preoperative intervention for anemia. The exception being iron deficiency anemia found during baseline. If laboratory values indicate iron deficiency, oral iron will be recommended to take until surgery.
|
|---|---|---|
|
Vascular disorders
Cerebrovascular Accident (CVA)
|
0.00%
0/2 • Adverse event data were collected from baseline to discharge of the index surgery, including a 30 day follow-up. The average in-patient length of stay was 7.4 days in hospital.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from baseline to discharge of the index surgery, including a 30 day follow-up. The average in-patient length of stay was 7.4 days in hospital.
|
Other adverse events
Adverse event data not reported
Additional Information
Philip Greilich -PROFESSOR
UT Southwestern Medical Center
Phone: 214/645-8018
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place