- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01601873
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Arkansas
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Little Rock, Arkansas, 미국, 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, 미국, 70121
- John Ochsner Heart & Vascular Institute Ochsner Medical Center
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
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Texas
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Houston, Texas, 미국, 77030
- Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
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Houston, Texas, 미국, 77089
- Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: PROPATEN
patients with heparin-bonded graft implantation
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Heparin-bonded graft implantation for hemodialysis vascular access
다른 이름들:
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활성 비교기: Standard Graft
patients undergoing ePTFE hemodialysis graft implantation
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non-heparin bonded conventional hemodialysis vascular access graft
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Primary Graft Patency Rate
기간: 12 months
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Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
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12 months
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Primary-Assisted Graft Patency Rate
기간: 12 months
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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.
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12 months
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Secondary Graft Patency Rate
기간: 12 months
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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.
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12 months
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Primary Graft Patency Rate
기간: 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.
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24 months after graft placement
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Primary-Assisted Graft Patency Rate
기간: 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.
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24 months after graft placement
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Secondary Graft Patency Rate
기간: 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.
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24 months after graft placement
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants With Complications or Morbidity Attributable to the Study
기간: at least 1 year but up to two years
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Complication/morbidity associated with both types of interventions
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at least 1 year but up to two years
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Cost Estimation and Analysis
기간: 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
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Quality of Life (QoL) Comparison
기간: Participants would be followed for a period of 2 years after graft placement
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Comparative assessment of quality of life reported by the patients in two arms
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Participants would be followed for a period of 2 years after graft placement
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Number of Postoperative Re-interventions
기간: at least 1 year but up to two years
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at least 1 year but up to two years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kristofer M Charlton-Ouw, MD, University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CTVS-KC01
- UTHSCMS-12/0095 (기타 식별자: UTHSC IRB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
PROPATEN에 대한 임상 시험
-
W.L.Gore & Associates완전한
-
W.L.Gore & Associates모병외상 부상 | 말초 동맥 질환 | 혈액 투석 액세스 | 슬와 동맥류 | 내장 동맥 동맥류스페인, 이탈리아, 독일, 스웨덴, 네덜란드, 영국, 프랑스, 벨기에, 그리스
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W.L.Gore & Associates모병말기 신장 질환 | AAA - 복부 대동맥류 | PAD - 말초 동맥 질환스페인, 이탈리아, 프랑스