Trial Outcomes & Findings for Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy (NCT NCT00737893)
NCT ID: NCT00737893
Last Updated: 2021-04-08
Results Overview
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
At 6 months post-surgery
Results posted on
2021-04-08
Participant Flow
Participant milestones
| Measure |
Erythropoietin (EPO)
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
27
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
57 years
n=7 Participants
|
55.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 months post-surgerySurvey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
|
14 score on a scale
Interval 6.5 to 24.0
|
19 score on a scale
Interval 8.0 to 23.0
|
SECONDARY outcome
Timeframe: At 3 months post-surgerySurvey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
|
11 score on a scale
Interval 6.0 to 22.0
|
14 score on a scale
Interval 6.0 to 23.0
|
SECONDARY outcome
Timeframe: At 9 months post-surgerySurvey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
|
20 score on a scale
Interval 8.0 to 27.0
|
25 score on a scale
Interval 12.0 to 28.0
|
SECONDARY outcome
Timeframe: At 12 months post-surgerySurvey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
|
22 score on a scale
Interval 15.5 to 26.0
|
28 score on a scale
Interval 18.0 to 30.0
|
SECONDARY outcome
Timeframe: At 3 months post-surgerySurvey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Overall IIEF Questionnaire
|
33 score on a scale
Interval 21.0 to 55.0
|
40 score on a scale
Interval 21.0 to 53.0
|
SECONDARY outcome
Timeframe: At 6 months post-surgerySurvey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Overall IIEF Questionnaire
|
37.5 score on a scale
Interval 28.5 to 52.0
|
51 score on a scale
Interval 32.0 to 55.0
|
SECONDARY outcome
Timeframe: At 9 months post-surgerySurvey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Overall IIEF Questionnaire
|
50 score on a scale
Interval 30.0 to 59.0
|
55 score on a scale
Interval 33.0 to 66.0
|
SECONDARY outcome
Timeframe: At 12 months post-surgerySurvey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Overall IIEF Questionnaire
|
53 score on a scale
Interval 39.0 to 62.0
|
60.5 score on a scale
Interval 44.0 to 68.0
|
SECONDARY outcome
Timeframe: At 3 months post-surgeryMental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
|
54.9 score on a scale
Interval 51.9 to 55.9
|
55.9 score on a scale
Interval 44.8 to 57.7
|
SECONDARY outcome
Timeframe: At 6 months post-surgeryMental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
|
55.9 score on a scale
Interval 49.4 to 58.3
|
55.0 score on a scale
Interval 50.6 to 57.8
|
SECONDARY outcome
Timeframe: At 9 months post-surgeryMental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
|
55.9 score on a scale
Interval 49.5 to 57.8
|
53.8 score on a scale
Interval 51.1 to 57.8
|
SECONDARY outcome
Timeframe: At 12 months post-surgeryMental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
|
55.3 score on a scale
Interval 51.8 to 57.5
|
55.9 score on a scale
Interval 51.4 to 57.9
|
SECONDARY outcome
Timeframe: At 3 months post-surgerySexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
|
43.6 score on a scale
Interval 28.2 to 68.6
|
49.4 score on a scale
Interval 31.4 to 63.5
|
SECONDARY outcome
Timeframe: At 6 months post-surgerySexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
|
47.8 score on a scale
Interval 35.9 to 65.1
|
53.2 score on a scale
Interval 37.8 to 72.5
|
SECONDARY outcome
Timeframe: At 9 months post-surgerySexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
|
59.6 score on a scale
Interval 41.7 to 75.0
|
70.5 score on a scale
Interval 37.8 to 80.8
|
SECONDARY outcome
Timeframe: At 12 months post-surgerySexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
|
62.2 score on a scale
Interval 46.5 to 77.9
|
73.7 score on a scale
Interval 48.1 to 86.5
|
SECONDARY outcome
Timeframe: At 3 months post-surgerySurvey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Quality of Erection Questionnaire (QEQ)
|
20.8 score on a scale
Interval 0.0 to 70.8
|
37.5 score on a scale
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: At 6 months post-surgerySurvey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Quality of Erection Questionnaire (QEQ)
|
37.5 score on a scale
Interval 0.0 to 70.8
|
45.8 score on a scale
Interval 0.0 to 75.0
|
SECONDARY outcome
Timeframe: At 9 months post-surgerySurvey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Quality of Erection Questionnaire (QEQ)
|
66.7 score on a scale
Interval 4.2 to 79.2
|
70.8 score on a scale
Interval 20.8 to 87.5
|
SECONDARY outcome
Timeframe: At 12 months post-surgerySurvey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Patient Score on the Quality of Erection Questionnaire (QEQ)
|
70.8 score on a scale
Interval 22.9 to 85.4
|
79.2 score on a scale
Interval 41.7 to 100.0
|
SECONDARY outcome
Timeframe: 2 weeks after surgeryHemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl).
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Hemoglobin Level at 2 Weeks After Surgery
|
14.7 g/dl
Interval 14.1 to 15.2
|
13.6 g/dl
Interval 13.1 to 14.4
|
SECONDARY outcome
Timeframe: During hospital stay, up to 1 weekAssess the number of participants requiring transfusion during hospitalization.
Outcome measures
| Measure |
Erythropoietin (EPO)
n=29 Participants
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 Participants
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Number of Participants Requiring Transfusion During Hospitalization
|
0 Participants
|
0 Participants
|
Adverse Events
Erythropoietin (EPO)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erythropoietin (EPO)
n=29 participants at risk
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 participants at risk
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Surgical and medical procedures
Clavien III
|
3.4%
1/29 • Number of events 1 • 1 year
Clavien-Dindo Complications (graded I, II, III, IV, and V) after surgery were assessed for all patients during hospitalization, at clinical follow-up visits, and via study survey follow-up. Clavien III or higher complications were considered serious.
|
3.7%
1/27 • Number of events 1 • 1 year
Clavien-Dindo Complications (graded I, II, III, IV, and V) after surgery were assessed for all patients during hospitalization, at clinical follow-up visits, and via study survey follow-up. Clavien III or higher complications were considered serious.
|
Other adverse events
| Measure |
Erythropoietin (EPO)
n=29 participants at risk
20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
Placebo
n=27 participants at risk
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|---|---|---|
|
Surgical and medical procedures
Clavien I-II
|
0.00%
0/29 • 1 year
Clavien-Dindo Complications (graded I, II, III, IV, and V) after surgery were assessed for all patients during hospitalization, at clinical follow-up visits, and via study survey follow-up. Clavien III or higher complications were considered serious.
|
11.1%
3/27 • Number of events 3 • 1 year
Clavien-Dindo Complications (graded I, II, III, IV, and V) after surgery were assessed for all patients during hospitalization, at clinical follow-up visits, and via study survey follow-up. Clavien III or higher complications were considered serious.
|
Additional Information
Dr. Hiten Patel
Johns Hopkins Brady Urological Institute
Phone: 410-502-7710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place