Trial Outcomes & Findings for Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa (NCT NCT00210626)
NCT ID: NCT00210626
Last Updated: 2014-04-21
Results Overview
Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
Hospital Discharge to Post-Hospital Discharge Week 24
Results posted on
2014-04-21
Participant Flow
ITT subjects were all randomized subjects. Three subjects were randomized prior to screening and failed screening. These 3 subjects did not receive any study medication or procedure prior to discontinuation and are not included in the 192 subjects that started the study.
Participant milestones
| Measure |
PROCRIT
40,000 IU/mL/week for maximum of 12 weeks
|
Placebo
Placebo given at equivalent volume (1 mL) as Procrit
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
95
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
48
|
45
|
Reasons for withdrawal
| Measure |
PROCRIT
40,000 IU/mL/week for maximum of 12 weeks
|
Placebo
Placebo given at equivalent volume (1 mL) as Procrit
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
29
|
20
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Sponser Request
|
1
|
0
|
|
Overall Study
Other
|
4
|
5
|
Baseline Characteristics
Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa
Baseline characteristics by cohort
| Measure |
PROCRIT
n=96 Participants
40,000 IU/mL/week for maximum of 12 weeks
|
Placebo
n=92 Participants
Placebo given at equivalent volume (1 mL) as Procrit
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hospital Discharge to Post-Hospital Discharge Week 24Population: ITT (Intent to Treat), The number of subjects analyzed includes all ITT subjects that did not withdraw from the study prior to hospital discharge.
Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.
Outcome measures
| Measure |
PROCRIT
n=85 Participants
40,000 IU/mL/week for maximum of 12 weeks
|
Placebo
n=81 Participants
Placebo given at equivalent volume (1 mL) as Procrit
|
|---|---|---|
|
SF-36 PF Score
|
27.30 Units on a scale.
Standard Deviation 23.668
|
30.88 Units on a scale.
Standard Deviation 23.522
|
SECONDARY outcome
Timeframe: Hospital Discharge to Post-Hospital Discharge Week 24Population: Intention to Treat(ITT)population and completed Week 24 Post-Hospital discharge.
Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.
Outcome measures
| Measure |
PROCRIT
n=35 Participants
40,000 IU/mL/week for maximum of 12 weeks
|
Placebo
n=37 Participants
Placebo given at equivalent volume (1 mL) as Procrit
|
|---|---|---|
|
Return to Usual Activity (RTUA)
|
9 Participants
|
11 Participants
|
Adverse Events
PROCRIT
Serious events: 17 serious events
Other events: 83 other events
Deaths: 0 deaths
Placebo
Serious events: 20 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PROCRIT
n=96 participants at risk
40,000 IU/mL/week for maximum of 12 weeks
|
Placebo
n=92 participants at risk
Placebo given at equivalent volume (1 mL) as Procrit
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/96
|
1.1%
1/92
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
1.0%
1/96
|
0.00%
0/92
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/96
|
1.1%
1/92
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/96
|
1.1%
1/92
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/96
|
1.1%
1/92
|
|
General disorders
Wound Necrosis
|
1.0%
1/96
|
1.1%
1/92
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Cellulitis
|
1.0%
1/96
|
1.1%
1/92
|
|
Infections and infestations
Abdominal Sepsis
|
1.0%
1/96
|
0.00%
0/92
|
|
Infections and infestations
Bacteraemia
|
1.0%
1/96
|
0.00%
0/92
|
|
Infections and infestations
Cystitis
|
1.0%
1/96
|
0.00%
0/92
|
|
Infections and infestations
Lung Infection Pseudomonal
|
1.0%
1/96
|
0.00%
0/92
|
|
Infections and infestations
Pneumonia
|
1.0%
1/96
|
0.00%
0/92
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
1/96
|
0.00%
0/92
|
|
Infections and infestations
Wound Infection Staphylococcal
|
1.0%
1/96
|
0.00%
0/92
|
|
Infections and infestations
Appendicitis
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Endocarditis
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Infected Skin Ulcer
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Localised Infection
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Septic Shock
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/96
|
1.1%
1/92
|
|
Infections and infestations
Wound Infection
|
0.00%
0/96
|
1.1%
1/92
|
|
Injury, poisoning and procedural complications
Haemothorax
|
1.0%
1/96
|
0.00%
0/92
|
|
Injury, poisoning and procedural complications
Implant Tissue Necrosis
|
1.0%
1/96
|
0.00%
0/92
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
1.0%
1/96
|
0.00%
0/92
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/96
|
2.2%
2/92
|
|
Injury, poisoning and procedural complications
Anemia Postoperative
|
0.00%
0/96
|
1.1%
1/92
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/96
|
1.1%
1/92
|
|
Injury, poisoning and procedural complications
Fracture Displacement
|
0.00%
0/96
|
1.1%
1/92
|
|
Injury, poisoning and procedural complications
Pneumothorax Traumatic
|
0.00%
0/96
|
1.1%
1/92
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.00%
0/96
|
1.1%
1/92
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
1/96
|
0.00%
0/92
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/96
|
0.00%
0/92
|
|
Musculoskeletal and connective tissue disorders
Aseptic necrosis Bone
|
0.00%
0/96
|
1.1%
1/92
|
|
Musculoskeletal and connective tissue disorders
Fracture Nonunion
|
0.00%
0/96
|
1.1%
1/92
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/96
|
1.1%
1/92
|
|
Nervous system disorders
Cerebellar Haematona
|
0.00%
0/96
|
1.1%
1/92
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/96
|
1.1%
1/92
|
|
Psychiatric disorders
Delirium
|
0.00%
0/96
|
1.1%
1/92
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/96
|
1.1%
1/92
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.0%
1/96
|
0.00%
0/92
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.1%
2/96
|
2.2%
2/92
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
1/96
|
2.2%
2/92
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.1%
1/92
|
1.1%
1/92
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Disorder
|
0.00%
0/92
|
1.1%
1/92
|
|
Vascular disorders
Deep Vein thrombosis
|
4.2%
4/96
|
4.3%
4/92
|
Other adverse events
| Measure |
PROCRIT
n=96 participants at risk
40,000 IU/mL/week for maximum of 12 weeks
|
Placebo
n=92 participants at risk
Placebo given at equivalent volume (1 mL) as Procrit
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
2/96
|
6.5%
6/92
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
7.3%
7/96
|
8.7%
8/92
|
|
Cardiac disorders
Tachycardia
|
2.1%
2/96
|
5.4%
5/92
|
|
Gastrointestinal disorders
Constipation
|
33.3%
32/96
|
40.2%
37/92
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
8/96
|
12.0%
11/92
|
|
Gastrointestinal disorders
Nausea
|
20.8%
20/96
|
28.3%
26/92
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
10/96
|
5.4%
5/92
|
|
General disorders
Odema Peripheral
|
5.2%
5/96
|
10.9%
10/92
|
|
General disorders
Pyrexia
|
19.8%
19/96
|
22.8%
21/92
|
|
Infections and infestations
Pneumonia
|
12.5%
12/96
|
9.8%
9/92
|
|
Infections and infestations
Urinary Tract Infection
|
13.5%
13/96
|
13.0%
12/92
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.0%
1/96
|
5.4%
5/92
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
12/96
|
8.7%
8/92
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.2%
4/96
|
5.4%
5/92
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.0%
1/96
|
5.4%
5/92
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.3%
8/96
|
9.8%
9/92
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.2%
6/96
|
10.9%
10/92
|
|
Nervous system disorders
Dizziness
|
5.2%
5/96
|
3.3%
3/92
|
|
Nervous system disorders
Headache
|
6.2%
6/96
|
8.7%
8/92
|
|
Psychiatric disorders
Agitation
|
7.3%
7/96
|
4.3%
4/92
|
|
Psychiatric disorders
Anxiety
|
6.2%
6/96
|
10.9%
10/92
|
|
Psychiatric disorders
Depression
|
7.3%
7/96
|
4.3%
4/92
|
|
Psychiatric disorders
Insomnia
|
27.1%
26/96
|
30.4%
28/92
|
|
Renal and urinary disorders
Urinary Retention
|
5.2%
5/96
|
5.4%
5/92
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
6/96
|
2.2%
2/92
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.2%
4/96
|
6.5%
6/92
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
2.1%
2/96
|
6.5%
6/92
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
6/96
|
14.1%
13/92
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
5/96
|
5.4%
5/92
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.2%
5/96
|
6.5%
6/92
|
Additional Information
Vice President Medical Affairs
Centocor Ortho Biotech Services, LLC (COBS)
Phone: 215-325-4464
Results disclosure agreements
- Principal investigator is a sponsor employee All information which is supplied by COBS to the investigator \& not previously published \& any data generated as a result of the study are confidential \& remain the sole property of COBS. Investigator will not use the information for other purposes without COBS prior written consent.
- Publication restrictions are in place
Restriction type: OTHER