Trial Outcomes & Findings for The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery (NCT NCT00350519)
NCT ID: NCT00350519
Last Updated: 2013-07-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Day of surgery until hospital discharge
Results posted on
2013-07-22
Participant Flow
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.
Participant milestones
| Measure |
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
|
STANDARD THERAPY
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
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
|
STANDARD THERAPY
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
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
The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
Baseline characteristics by cohort
| Measure |
PROCRIT (Epoetin Alfa)
n=18 Participants
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
|
STANDARD THERAPY
n=19 Participants
Participants received standard of care based on the Institution's treatment policy
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age Continuous
|
63.06 years
STANDARD_DEVIATION 16.17 • n=5 Participants
|
61.42 years
STANDARD_DEVIATION 18.32 • n=7 Participants
|
62.22 years
STANDARD_DEVIATION 17.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or Aftrican American
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of surgery until hospital dischargePopulation: ITT(intention to treat), No formal analysis was conducted due to early termination and small sample size
Outcome measures
| Measure |
PROCRIT (Epoetin Alfa)
n=18 Participants
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
|
STANDARD THERAPY
n=19 Participants
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions
|
4 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 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
End of Study Hemoglobin minus baseline Hemoglobin
Outcome measures
| Measure |
PROCRIT (Epoetin Alfa)
n=13 Participants
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
|
STANDARD THERAPY
n=13 Participants
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
Hemoglobin Change From Baseline to End of Study
|
0.98 g/dL
Standard Deviation 1.39
|
0.33 g/dL
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline (Day -10) to end of study (Day 32)Population: ITT, No formal analysis was conducted due to early termination and small sample size
Outcome measures
| Measure |
PROCRIT (Epoetin Alfa)
n=4 Participants
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
|
STANDARD THERAPY
n=9 Participants
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
Number of pRBC Units Transfused During Study
|
3.5 units
Standard Deviation 3.00
|
6.11 units
Standard Deviation 7.98
|
SECONDARY outcome
Timeframe: Surgery to hospital dischargePopulation: ITT, No formal analysis was conducted due to early termination and small sample size
Outcome measures
| Measure |
PROCRIT (Epoetin Alfa)
n=17 Participants
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
|
STANDARD THERAPY
n=16 Participants
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
Hospital Length of Stay
|
7.94 days
Standard Deviation 5.17
|
12.56 days
Standard Deviation 12.30
|
Adverse Events
PROCRIT (Epoetin Alfa)
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
STANDARD THERAPY
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PROCRIT (Epoetin Alfa)
n=18 participants at risk
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
|
STANDARD THERAPY
n=19 participants at risk
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
Infections and infestations
Abdominal abscess
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
11.1%
2/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Investigations
Anticoagulation drug level below therapurtic
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Investigations
International normalized ratio increased
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Metabolism and nutrition disorders
Hypergylcaemia
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Renal and urinary disorders
Renal failure
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Renal and urinary disorders
Ureteric obstruction
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Vascular disorders
Thrombosis
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
Other adverse events
| Measure |
PROCRIT (Epoetin Alfa)
n=18 participants at risk
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
|
STANDARD THERAPY
n=19 participants at risk
Participants received standard of care based on the Institution's treatment policy
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Cardiac disorders
Tachycardia
|
11.1%
2/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Gastrointestinal disorders
Diverticulum
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Gastrointestinal disorders
Faecaloma
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • 64 days
|
31.6%
6/19 • 64 days
|
|
Gastrointestinal disorders
Pancreatic fistula
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Gastrointestinal disorders
Stomach discomfort
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
4/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
General disorders
Asthenia
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
General disorders
Feeling hot
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
General disorders
Pain
|
11.1%
2/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
General disorders
Pyrexia
|
11.1%
2/18 • 64 days
|
36.8%
7/19 • 64 days
|
|
Infections and infestations
Application site infection
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Infections and infestations
Rhinitis
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Infections and infestations
Staphylococcal infection
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Injury, poisoning and procedural complications
Head injury
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Injury, poisoning and procedural complications
Incision site complication
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
5.6%
1/18 • 64 days
|
15.8%
3/19 • 64 days
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
16.7%
3/18 • 64 days
|
26.3%
5/19 • 64 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Investigations
Blood potassium decreased
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Investigations
Body temperature increased
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Investigations
Platelet count increased
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Investigations
Prothrombin level increased
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Investigations
Prothrombin time prolonged
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Investigations
Urine output decreased
|
5.6%
1/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
1/18 • 64 days
|
15.8%
3/19 • 64 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Psychiatric disorders
Confusional state
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Psychiatric disorders
Hallucination
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Psychiatric disorders
Mental status changes
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Renal and urinary disorders
Renal failure
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • 64 days
|
10.5%
2/19 • 64 days
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Vascular disorders
Hypotension
|
22.2%
4/18 • 64 days
|
5.3%
1/19 • 64 days
|
|
Gastrointestinal disorders
Faeces discoloured
|
5.6%
1/18 • 64 days
|
0.00%
0/19 • 64 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.1%
2/18 • 64 days
|
26.3%
5/19 • 64 days
|
Additional Information
Vice President Medical Affairs COBS
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 215-325-4464
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60