- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00236405
PROCRIT and Short-Term Outcomes in Orthopedic Surgery
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of of PROCRIT� (Epoetin Alfa) on Short-Term Outcomes in Orthopedic Subjects Undergoing Primary Unilateral Knee Arthroplasty
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The primary objective of this study is to compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on post-operative rehabilitation outcomes in subjects undergoing primary unilateral knee arthroplasty.
Secondary objectives are : 1) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on hemoglobin, change in hemoglobin, number of units transfused and transfusion rate during the study period; and 2) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on inpatient rehabilitation length of stay.
The study will test the hypothesis that perioperative administration of PROCRIT will improve post-operative rehabilitation outcomes, compared with preoperative autologous donation. 40,000U PROCRIT or Placebo SC in relation to surgery date: Days -21, -14, -7, 0 (day of surgery), 7, and 14.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Scheduled for primary unilateral knee arthroplasty with an expected discharge into an inpatient rehabilitation facility
- Hemoglobin >11 to <13 g/dL at screening and preoperative day -21
- Age 18 years or older
- Female subjects must be post-menopausal for at least one year or surgically sterile (hysterectomy or tubal ligation). Women of childbearing age must have negative pregnancy test(s) (serum HCG RIA at screening and urine at preoperative day -21, if applicable
- Preoperative lead time of at least 21 days
Exclusion Criteria:
- Medical conditions including: Known iron deficiency (defined as serum ferritin <50 mg/l)
- chronic renal failure, significant hematological disease, uncontrolled hypertension, new onset seizures/uncontrolled seizures
- Expected to need another lower extremity major joint replacement within six months
- Undergoing cancer chemotherapy
- History of thrombotic vascular events including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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The primary endpoint is the change in composite FIM scores (from entry into the inpatient rehabilitation facility to discharge from inpatient rehabilitation) divided by the LOS, denoted as DFIM/LOS, or "rate of functional recovery".
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Sekundære resultatmål
Resultatmål |
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LOS in the inpatient rehabilitation facility; Total FIM score; FIM Physical Sub-score LASA score; FACIT-An score. Safety evaluations include the incidence of adverse events throughout the study
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR003193
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Kliniske forsøg med epoetin alfa
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Hospital de Clinicas de Porto AlegreOswaldo Cruz Foundation; Rio Grande do Sul State Health Department - SES...AfsluttetSammenligning af effektiviteten af to formuleringer af epoetin hos patienter, der gennemgår hæmodialyse
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MegalabsAzidus LaboratoriesIkke rekrutterer endnuAnæmi af kronisk nyresygdomUruguay
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M.D. Anderson Cancer CenterAfsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech, Inc.Afsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Afsluttet
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Johnson & Johnson Pharmaceutical Research & Development...AfsluttetBlodtransfusion | Ortopædkirurgi | Ortopædiske procedurer | Mammaplastik | Kardiovaskulære kirurgiske procedurer | Blodtransfusion, autolog
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Afsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Afsluttet
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Hoffmann-La RocheAfsluttet
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Afsluttet