Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Composite efficacy outcome of full-scare trial #1
研究概览
简要总结
The goal of this clinical trial is to test the feasibility of the study protocol comparing a novel temperature control system - Xo Port Organ Preservation System - to static ice for heat preservation for Heart Transplant. The main questions of the study are as follows:
Does the Incidence of severe PGD change within the first 24 hours of heart transplant in patients randomized to the Xo Port Organ Preservation System?
Was there a change in composite efficacy endpoints in participants randomized to the Xo Port Organ Preservation System compared to static ice storage?
Were the feasibility outcomes achieved?
Were there any protocol deviations?
Participants will:
Be randomized to either the Xo Port Organ Preservation System or static ice storage.
Complete a questionnaire at the time of screening, day 0, 7, and 90 days post transplant.
Have blood drawn - with their standard of care blood draws - after their transplant, the day after, and 7 days post transplant.
详细描述
The PROTECT-PGD Pilot trial is a 2.5 year, 50-patient, multi-centre, feasibility, randomized, blinded, controlled pilot trial assessing feasibility of a full-scale blinded randomized controlled trial to determine whether use of the Xo Port Organ Preservation System (Traferox Technologies Inc.), a novel temperature controlled system that maintains donor heart temperature between 8 and 12°C reduces the risk of severe PGD in patients post HT. If feasibility is demonstrated, pilot trial participants will be included in the full-scale trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The participant and all study personnel will be blinded to the treatment arm the participant is randomized to - with exception to the unblinded research assistant that will be performing the randomization and allocation process.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient: Adult (>17 years old)
- •Donor: Donation after brain death acceptable for transplant as determined by a procuring physician unaware of randomization sequence at the time of acceptance
排除标准
- •Recipient: Multi-organ transplant recipients; Participating in an interventional study.
- •Donor: Donation after cardiac death; Use of organ care system
研究组 & 干预措施
Xo Port Organ Preservation System
Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage
干预措施: Xo Port Organ Preservation System (Device)
Static Ice Storage
Traferox Transport System containing ice-packs as used for conventional cold static storage
干预措施: Standard of Care - Ice packs (Device)
结局指标
主要结局
Composite efficacy outcome of full-scare trial #1
时间窗: 2.5 years
90-day mortality
Composite efficacy outcome of full-scare trial #2
时间窗: 2.5 years
severe PGD (defined through the ISHLT consensus definition need for MCS will be adjudicated in a blinded fashion with LVEF\<40% and CI\<2.0 on high dose inotropes
Composite efficacy outcome of full-scare trial #3
时间窗: 2.5 years
duration of mechanical ventilation
Composite efficacy outcome of full-scare trial #4
时间窗: 2.5 years
ICU length of stay (LOS)
Composite efficacy outcome of full-scare trial #5
时间窗: 2.5 years
index transplant LOS
Composite efficacy outcome of full-scare trial #6
时间窗: 2.5 years
Moderate to severe rejection based on ISHLT criteria at 90 days
Composite efficacy outcome of full-scare trial #7
时间窗: 2.5 years
change in EQ-5D-5L utility index score from baseline to 90 days with a clinically meaningful change defined as \>0.05
Composite efficacy outcome of full-scare trial #8
时间窗: 2.5 years
cfDNA count measured over POD0, POD1, and POD7
Primary Study Feasibility
时间窗: 2.5 years
Determined by the mean number of participants recruited per month calculated on recruitment over 24 months.
Composite efficacy outcome of full-scare trial 1
时间窗: 2.5 years
90-day mortality
Composite efficacy outcome of full-scare trial 2
时间窗: 2.5 years
severe PGD (defined through the ISHLT consensus definition need for MCS will be adjudicated in a blinded fashion with LVEF\<40% and CI\<2.0 on high dose inotropes
Composite efficacy outcome of full-scare trial 3
时间窗: 2.5 years
duration of mechanical ventilation
Composite efficacy outcome of full-scare trial 4
时间窗: 2.5 years
ICU length of stay (LOS)
Composite efficacy outcome of full-scare trial 5
时间窗: 2.5 years
index transplant LOS
Composite efficacy outcome of full-scare trial 6
时间窗: 2.5 years
Moderate to severe rejection based on ISHLT criteria at 90 days
Composite efficacy outcome of full-scare trial 7
时间窗: 2.5 years
change in EQ-5D-5L utility index score from baseline to 90 days with a clinically meaningful change defined as \>0.05
Composite efficacy outcome of full-scare trial 8
时间窗: 2.5 years
cfDNA count measured over POD0, POD1, and POD7
次要结局
未报告次要终点