Hemostasis, Surgical
Conditions
Keywords
Hemostasis, Surgical, Epoetin alfa, Surgery, Abdomen, Pelvis, PROCRIT, pRBC, Blood transfusion, Packed red blood cell transfusion
Brief summary
The primary purpose of the study is to compare the effect of perioperative (the time period describing the duration of a participants surgical procedure) administration of PROCRIT to that of Standard of Care (SOC) on the proportion of participants receiving pRBC (packed red blood cells) transfusions (from the day of surgery to the day of hospital discharge) in participants undergoing elective major abdominal and/or pelvic surgery. Standard of Care is defined as the treatment of participants according to the hospital or institution's policy, but where participants will not receive PROCRIT (Epoetin alfa) or any other erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production of red blood cells in the bone marrow).
Detailed description
This is a randomized (the study medication is assigned by chance), parallel-arm (each group of participants will be treated at the same time), open-label (all people know the identity of the intervention), multicenter study. The study consists of screening phase of 21 days, treatment phase of 15 days, follow-up phase of 28 days. Approximately 110 participants undergoing elective major abdominal and/or pelvic surgery will be enrolled. During the Treatment Phase, eligible participants will be randomly assigned (participants are assigned to a treatment group based on chance) in a 1:1 ratio to either PROCRIT (Epoetin alfa) or the Standard of Care (SOC) group that will not receive any erythropoiesis-stimulating agents (ESAs). Participants will undergo surgery during the Treatment Phase. After surgery, all participants will stay in the study for 4 days (or until hospital discharge) and followed for an additional 28 days (Follow-up Phase). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The duration of the study for each participant will be approximately 64 days.
Interventions
DRUGEpoetin alfa
Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
DRUGStandard of Care
Participants will receive standard of care based on the Institution's treatment policy.
Sponsors
Ortho Biotech Clinical Affairs, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Scheduled to undergo elective major abdominal and/or pelvic surgery with anticipated significant perioperative ((the time period describing the duration of a participants surgical procedure) blood loss (eg, greater than 500 cc and at increased risk for blood transfusion) - Hemoglobin greater than 10 g/dL and less than or equal to 13 g/dL at screening (Day -13 \[13 days prior to surgery\] to Day -11) and baseline (Day -10) - Patients with reproductive potential and their partners must practice an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, partner sterilization) before entry and throughout the study - Female patients with reproductive potential must have a negative urine pregnancy test within 7 days of the first dose of PROCRIT - Adequate renal (kidney) and adequate hepatic (liver) function assessed within the 21-day screening period
Exclusion criteria
- No severe Congestive Heart Failure (New York Heart Association Class IV) - No known severe stable or unstable coronary artery disease, or unstable angina - No history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months before study entry (prior superficial thrombophlebitis is not an exclusion criterion) - No history of cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute coronary syndrome (unstable Angina, myocardial Infarction), or other arterial thrombosis within 6 months before study entry - Not anticipated to donate perioperative autologous blood or receive transfusions within 21 days prior to baseline or to have greater than 6 transfusions perioperatively - No prior treatment with PROCRIT or any erythropoiesis-stimulating agents (ESAs) within the previous month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions | Day of surgery until hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Change From Baseline to End of Study | Baseline (Day-10) to end of study (Day 32) | End of Study Hemoglobin minus baseline Hemoglobin |
| Number of pRBC Units Transfused During Study | Baseline (Day -10) to end of study (Day 32) | — |
| Hospital Length of Stay | Surgery to hospital discharge | — |
Participant flow
Pre-assignment details
37 participants were enrolled in the study. 18 participants were randomly assigned to the epoetin alfa group and 19 were randomly assigned to the Standard therapy group.
Participants by arm
| Arm | Count |
|---|---|
| PROCRIT (Epoetin Alfa) Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery | 18 |
| STANDARD THERAPY Participants received standard of care based on the Institution's treatment policy | 19 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | PROCRIT (Epoetin Alfa) | STANDARD THERAPY | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 12 Participants | 23 Participants |
| Age Continuous | 63.06 years STANDARD_DEVIATION 16.17 | 61.42 years STANDARD_DEVIATION 18.32 | 62.22 years STANDARD_DEVIATION 17.08 |
| Race/Ethnicity, Customized Black or Aftrican American | 0 participants | 5 participants | 5 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized White | 17 participants | 12 participants | 29 participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 18 | 13 / 19 |
| serious Total, serious adverse events | 5 / 18 | 8 / 19 |
Outcome results
Primary
Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions
Time frame: Day of surgery until hospital discharge
Population: ITT(intention to treat), No formal analysis was conducted due to early termination and small sample size
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROCRIT (Epoetin Alfa) | Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions | 4 participants |
| STANDARD THERAPY | Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions | 9 participants |
Secondary
Hemoglobin Change From Baseline to End of Study
End of Study Hemoglobin minus baseline Hemoglobin
Time frame: Baseline (Day-10) to end of study (Day 32)
Population: All Subjects, No formal analysis was conducted due to early termination and small sample size
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCRIT (Epoetin Alfa) | Hemoglobin Change From Baseline to End of Study | 0.98 g/dL | Standard Deviation 1.39 |
| STANDARD THERAPY | Hemoglobin Change From Baseline to End of Study | 0.33 g/dL | Standard Deviation 2.06 |
Secondary
Hospital Length of Stay
Time frame: Surgery to hospital discharge
Population: ITT, No formal analysis was conducted due to early termination and small sample size
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCRIT (Epoetin Alfa) | Hospital Length of Stay | 7.94 days | Standard Deviation 5.17 |
| STANDARD THERAPY | Hospital Length of Stay | 12.56 days | Standard Deviation 12.3 |
Secondary
Number of pRBC Units Transfused During Study
Time frame: Baseline (Day -10) to end of study (Day 32)
Population: ITT, No formal analysis was conducted due to early termination and small sample size
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCRIT (Epoetin Alfa) | Number of pRBC Units Transfused During Study | 3.5 units | Standard Deviation 3 |
| STANDARD THERAPY | Number of pRBC Units Transfused During Study | 6.11 units | Standard Deviation 7.98 |