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临床试验/NCT01190059
NCT01190059已完成1 期

Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

XVIVO Perfusion1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
PGD scores in the first 72 hours after lung transplantation.

研究概览

简要总结

The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation.

详细描述

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.

These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • 未提供

排除标准

  • Significant mechanical lung injury - contusion
  • Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis

研究组 & 干预措施

EVLP Group

Experimental

EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the ex vivo lung perfusion system with Steen Solution™ .

干预措施: Ex vivo lung perfusion with Steen Solution™ (Drug)

结局指标

主要结局

PGD scores in the first 72 hours after lung transplantation.

时间窗: 72 hours

Immediate lung function is one of the key factors in determining the impact of donor lung quality, therefore the PGD score within 72 hrs was selected as the primary endpoint.

30 day Mortality

时间窗: 30 days

Mortality at 30 days post transplant

次要结局

  • Extra-corporeal membrane oxygenation use(30 days)
  • Bronchial complications(30 days)
  • Ventilator duration(30 days)
  • Intensive Care Unit length of stay(30 days)
  • Hospital length of stay(30 days)

研究者

发起方
XVIVO Perfusion
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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