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临床试验/NCT03639025
NCT03639025进行中(未招募)不适用

The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation

TransMedics18 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2018年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
TransMedics
入组人数
458
试验地点
18
主要终点
12-month patient and graft survival post double-lung transplant

研究概览

简要总结

Single-arm, prospective, multi-center, post-approval U.S. registry

详细描述

This is an all-comers registry that will enroll:

  1. Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
  2. Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
  3. All donor lungs that were perfused on OCS Lung System.

Enrolled patients will fall into one of the following three possible analysis categories:

  1. TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  2. TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  3. All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

12-month patient and graft survival post double-lung transplant

时间窗: 12 months

Primary Effectiveness Endpoint

次要结局

  • Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation(72 hours)
  • Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs(2 hours)
  • Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation(Within 72 hours post-transplantation)
  • Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)(0, 24, 48 and 72 hours)
  • Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate(1 hour)

研究者

发起方
TransMedics
申办方类型
Industry
责任方
Sponsor

研究点 (18)

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