Trial Outcomes & Findings for The Benefits of a Preoperative Anemia Management Program (NCT NCT01888003)
NCT ID: NCT01888003
Last Updated: 2015-05-28
Results Overview
The number of subjects who had blood transfusions (at least 1) during surgery
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
During surgery (less than 1 day)
Results posted on
2015-05-28
Participant Flow
Participant milestones
| Measure |
Anemia Treatment Group (AMG)
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb \< 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has
|
Conventional Treatment Group (CTG)
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
Non Anemia Group (NAG)
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
40
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
40
|
Reasons for withdrawal
| Measure |
Anemia Treatment Group (AMG)
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb \< 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has
|
Conventional Treatment Group (CTG)
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
Non Anemia Group (NAG)
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
|---|---|---|---|
|
Overall Study
Study Terminated
|
5
|
6
|
40
|
Baseline Characteristics
The Benefits of a Preoperative Anemia Management Program
Baseline characteristics by cohort
| Measure |
Anemia Treatment Group (AMG)
n=5 Participants
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb \< 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has
|
Conventional Treatment Group (CTG)
n=6 Participants
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
Non Anemia Group (NAG)
n=40 Participants
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 Years
n=5 Participants
|
62 Years
n=7 Participants
|
62 Years
n=5 Participants
|
62 Years
n=4 Participants
|
|
Sex/Gender, Customized
Males
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
25 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Sex/Gender, Customized
Females
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
40 participants
n=5 Participants
|
51 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During surgery (less than 1 day)The number of subjects who had blood transfusions (at least 1) during surgery
Outcome measures
| Measure |
Anemia Treatment Group (AMG)
n=5 Participants
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb \< 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has
|
Conventional Treatment Group (CTG)
n=6 Participants
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
Non Anemia Group (NAG)
n=40 Participants
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
|---|---|---|---|
|
Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: post surgery through discharge, an average of 2 daysNumber of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital
Outcome measures
| Measure |
Anemia Treatment Group (AMG)
n=5 Participants
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb \< 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has
|
Conventional Treatment Group (CTG)
n=6 Participants
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
Non Anemia Group (NAG)
n=40 Participants
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb \< 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
|---|---|---|---|
|
Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: post hospital discharge through 90 days after surgeryPopulation: Subjects dropped out of study prior to day 90
number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgeryPopulation: No subject data was analyzed.
Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale
Outcome measures
Outcome data not reported
Adverse Events
Anemia Treatment Group (AMG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Treatment Group (CTG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non Anemia Group (NAG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thomas Vetter
University of Alabama at Birmingham Department of Anesthesiology and Perioperative Medicine
Phone: 205.934.6501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place