A Stepped-Wedge Cluster Randomized Trial of the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway for Adults With Advanced Heart Failure in Latin America
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 主要终点
- Completion of Multidisciplinary Advanced Heart Failure Evaluation and Documented Transplant Candidacy Decision Within 90 Days
研究概览
简要总结
TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy decision. Participating network clusters transition from usual local pathways to the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway. The primary outcome is completion of multidisciplinary evaluation and a documented transplant-candidacy decision within 90 days after enrollment. The study also examines pathway activation, barriers, clinical outcomes, waiting-list trajectories, and traceable donor-organ opportunities. Enrollment does not constitute placement on an official waiting list, organ allocation, or authorization of cross-border care.
详细描述
Each TORCH regional network cluster is anchored in an authorized transplant center and may include activated evaluation, referral, identification, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Adults may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. The transplant center and competent authorities retain all legal and clinical authority for candidacy, waiting-list activation, organ acceptance, allocation, and transplantation.
The recipient pathway records identification, referral, enrollment, completion of multidisciplinary evaluation, documented candidacy decision, barrier management, activation of an authorized pathway or official waiting list, clinical change while waiting, donor-recipient opportunity, transplantation, or an alternative outcome. Study enrollment is analytically distinct from transplant candidacy and official wait-list status.
The donor-organ pathway records identification of a possible donor, confirmation of the applicable donation pathway, authorization, organ characterization, activation of an evaluable donor-organ opportunity, compatibility assessment, organ acceptance or rejection, procurement, preservation, transport, implantation, and final disposition. Donation after brain death and donation after circulatory determination of death are represented as distinct branches; normothermic regional perfusion is recorded only when applicable.
The two pathways converge at a traceable donor-organ-recipient matching episode. A characterized organ may be assessed for more than one compatible recipient, and each offer, decision, reason for non-acceptance, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority and does not override governmental or institutional systems.
Interoperability may range from audited manual transfer to structured documents, batch exchange, application programming interfaces, standards-based exchange, or validated remote-monitoring devices. Lack of an automated interface does not by itself exclude a site or participant when an authorized, secure, timely, and auditable fallback is available. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Advanced heart failure or acquired or structural heart disease meeting a protocol-defined trigger for specialized heart transplant evaluation.
- •Identification within an activated TORCH network cluster with an operational route to at least one authorized transplant center.
- •Ability to complete the protocol-defined follow-up directly or through an authorized network pathway.
- •Provision of informed consent according to applicable requirements.
排除标准
- •Primary congenital heart disease managed under the pediatric or congenital TORCH protocol.
- •No authorized route for protocol evaluation or follow-up at the time of enrollment.
- •Unable or unwilling to provide informed consent when required.
- •The prespecified multidisciplinary evaluation and transplant-candidacy decision were already completed before the enrollment reference time.
研究组 & 干预措施
TORCH Integrated Pathway Period
Participants enrolled while their cluster is assigned to the intervention period receive the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway, including protocolized identification and referral, multidisciplinary evaluation, candidacy adjudication, barrier navigation, pathway and wait-list status tracking, and traceable donor-organ opportunity coordination when applicable.
干预措施: TORCH Adult Heart Transplant Evaluation and Candidacy Pathway (Other)
Usual Local Pathway Period
Participants enrolled before their cluster transitions to the TORCH pathway receive the locally available referral, evaluation, treatment, and transplant-candidacy processes. Study data collection does not alter the legal authority of local transplant programs or competent authorities.
结局指标
主要结局
Completion of Multidisciplinary Advanced Heart Failure Evaluation and Documented Transplant Candidacy Decision Within 90 Days
时间窗: Within 90 days after enrollment.
Percentage of eligible enrolled participants who complete the prespecified multidisciplinary advanced heart failure evaluation and have a documented transplant-candidacy decision within 90 days after enrollment. A completed decision includes candidate for pathway or wait-list activation, conditional candidate with modifiable risk, not a candidate for isolated heart transplantation, too stable or transplant not currently indicated, or an alternative therapeutic pathway. An incomplete evaluation is not counted as success.
次要结局
- Activation of an Authorized Pathway or Official Waiting List(Within 180 days after the first documented transplant-candidacy decision qualifying for pathway or waitlist activation.)
- Time to Completed Evaluation and Candidacy Decision(From enrollment to completed evaluation and documented candidacy decision, assessed through 180 days.)
- Participant-Level Barriers to Evaluation and Pathway Activation(Through 90 days after enrollment.)
- Resolution of Identified Barriers(Within 180 days after identification of each barrier.)
- Heart Transplantation(Through 24 months after enrollment.)
- Death or Irreversible Clinical Deterioration(Through 24 months after enrollment.)
- Durable Mechanical Circulatory Support Implantation(24 months after enrollment.)
- Utilization of TORCH-Evaluated Donor Organs(Perioperative/periprocedural period; at final disposition of each donor organ.)