The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
2. juli 2013 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open Label, Multicenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal and/or Pelvic Surgery
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).
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
37
Fase
- Fase 4
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: PROCRIT (epoetin alfa)
Participants will receive PROCRIT (epoetin 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.
Andre navn:
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Eksperimentell: STANDARD THERAPY
Participants will receive standard of care.
|
Participants will receive standard of care based on the Institution's treatment policy.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions
Tidsramme: Day of surgery until hospital discharge
|
Day of surgery until hospital discharge
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hemoglobin Change From Baseline to End of Study
Tidsramme: Baseline (Day-10) to end of study (Day 32)
|
End of Study Hemoglobin minus baseline Hemoglobin
|
Baseline (Day-10) to end of study (Day 32)
|
|
Number of pRBC Units Transfused During Study
Tidsramme: Baseline (Day -10) to end of study (Day 32)
|
Baseline (Day -10) to end of study (Day 32)
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|
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Hospital Length of Stay
Tidsramme: Surgery to hospital discharge
|
Surgery to hospital discharge
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. august 2006
Primær fullføring (Faktiske)
1. februar 2008
Studiet fullført (Faktiske)
1. februar 2008
Datoer for studieregistrering
Først innsendt
7. juli 2006
Først innsendt som oppfylte QC-kriteriene
7. juli 2006
Først lagt ut (Anslag)
10. juli 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. juli 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2013
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR012460
- EPOSUR4005 (Annen identifikator: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
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