Propaten Randomized Investigation on Cost-benefit and Efficacy (PRICE)
A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Study Design: This is a prospective, multi-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing heparin-bonded (Propaten®) versus non-heparin-bonded arteriovenous grafts.
Procedure: In patients without usable native vein, prosthetic arteriovenous grafts will be implanted for hemodialysis access. Patients will be randomized intraoperatively to either conventional (Gore® Stretch) or heparin-bonded grafts (Gore® Propaten).
Course of Study: The study will accrue patients over the course of 5 years.
Enrollment: Enrollment will consist of adult patients who require hemodialysis. If the patient cannot have a native vein arteriovenous fistula, the patient is a candidate for arteriovenous graft. Patients will be screened and consented preoperatively. If the intraoperative decision is made that the patient will require a graft, randomization will occur and the patient will be considered enrolled.
Recruitment: The target population comprises of all adult patients aged 18 years and above with end stage renal disease requiring arteriovenous access for hemodialysis. The target for enrollment will be 200 patients.
Risks: The standard or known adverse events associated with graft implantation include thrombosis, infection, pseudoaneurysm, hematoma, and venous stenosis. There are case reports of heparin sensitivity. The investigators do not expect any additional physical risks other than an unintentional disclosure of sensitive patient health information.
Data Safety Monitoring: As the Principal Investigator of this study, Dr. Charlton-Ouw from the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston Medical School will conduct the data safety monitoring of this study. He will annually meet with all other co-investigators to review the patients enrolled in this study. As part of the data safety monitoring plan, all patients enrolled until that point in time would be unblinded in order to review the outcomes. Interim analyses will be conducted at the one-year follow up time.
IND#: The devices that will be used are already approved by the FDA and do not have IND#.
Proposed Funding Source: The study is internally funded.
Communication of Study Results: The communication of study results will occur only between authorized individuals who are listed to take part in the study through our department. The individuals who will take part in the study will acknowledge and adhere to the importance of patient safety and the protection of their private information. The results of this study will be analyzed and published after the approval of the principal investigator, co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented at an international/national scientific conference or meeting regardless of outcome.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- John Ochsner Heart & Vascular Institute Ochsner Medical Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
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Houston, Texas, Estados Unidos, 77089
- Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Aged ≥18 years of all ethnicities
- End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) per National Kidney Foundation guidelines
- Currently undergoing hemodialysis with a failure of previous access
- Expected to undergo hemodialysis within 6 months of presentation
Exclusion Criteria:
- Unable/refuse to abide with follow-up
- Known hypercoagulability syndrome or a bleeding disorder
- On a previous anticoagulant treatment
- Intraoperative decision in favor of fistula instead of graft
- Pregnant or breast-feeding women
- A documented history of heparin induced thrombocytopenia or allergy
- Active infections
- Evidence or suspicion of central vein stenosis
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: PROPATEN
patients with heparin-bonded graft implantation
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Heparin-bonded graft implantation for hemodialysis vascular access
Outros nomes:
|
|
Comparador Ativo: Standard Graft
patients undergoing ePTFE hemodialysis graft implantation
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non-heparin bonded conventional hemodialysis vascular access graft
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Primary Graft Patency Rate
Prazo: 12 months
|
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
|
12 months
|
|
Primary-Assisted Graft Patency Rate
Prazo: 12 months
|
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
|
12 months
|
|
Secondary Graft Patency Rate
Prazo: 12 months
|
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.
|
12 months
|
|
Primary Graft Patency Rate
Prazo: 24 months after graft placement
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Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
|
24 months after graft placement
|
|
Primary-Assisted Graft Patency Rate
Prazo: 24 months after graft placement
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Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
|
24 months after graft placement
|
|
Secondary Graft Patency Rate
Prazo: 24 months after graft placement
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Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.
|
24 months after graft placement
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Complications or Morbidity Attributable to the Study
Prazo: at least 1 year but up to two years
|
Complication/morbidity associated with both types of interventions
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at least 1 year but up to two years
|
|
Cost Estimation and Analysis
Prazo: During the study period based on an average participant follow-up of 2 years after graft placement
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Will be based on the difference between total cost analysed on the basis of the specific graft price, cost of re-intervention procedures if any, treatment of complications, hospital stay, etc., and compared for each study arm.
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During the study period based on an average participant follow-up of 2 years after graft placement
|
|
Quality of Life (QoL) Comparison
Prazo: Participants would be followed for a period of 2 years after graft placement
|
Comparative assessment of quality of life reported by the patients in two arms
|
Participants would be followed for a period of 2 years after graft placement
|
|
Number of Postoperative Re-interventions
Prazo: at least 1 year but up to two years
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at least 1 year but up to two years
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Kristofer M Charlton-Ouw, MD, University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CTVS-KC01
- UTHSCMS-12/0095 (Outro identificador: UTHSC IRB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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