NCT06770023招募中1 期
A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Survival until transplant
研究概览
简要总结
The purpose of this study is to determine if transseptal extra-corporeal membrane oxygenation (ECMO) can bridge pulmonary hypertension- right heart failure (PH-RVF) patients to lung transplant safely.
详细描述
Results will be released as a manuscript once it has gone through the peer review process. Results will be released even in the event of negative outcomes and the release will be hastened if the study is terminated early.
Medicare beneficiaries may be affected by the device under investigation if they are candidates for lung transplant. Since this is such a select group of patients, we do not expect the results of this trial to be generalizable to the general Medicare population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are listed for lung transplantation and have:
- •PH defined as:
- •Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) ≥ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) < 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units
- •Group 3 PH is defined as the presence of chronic lung disease (CLD) and/or hypoxia and mean pulmonary artery pressure (PAP) ≥ 20 mm Hg.
- •Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1) (to include Eisenmenger syndrome).
- •Failing right ventricle function defined as:
- •a cardiac (CI) index < 2.2 L/min/m^2 despite continuous infusion of high dose inotropes defined as:
- •Inhaled nitric oxide > 20 ppm and one of the following:
- •Dobutamine > 10 ug/kg/min x 15 minutes or
- •Milrinone > 0.5 ug/kg/min x 120 minutes or
- •Epinephrine > 0.5 ug/kg/min x 15 minutes or
- •Norepinephrine > 0.5 ug/kg/min x 15 minutes and have one of the following:
- •central venous pressure (CVP) > 15 mm Hg
- •global RV dysfunction on echocardiography defined as one of the following:
- •a tricuspid annular plane systolic excursion score of <14mm
- •an RV diameter at base >42mm
- •RV short-axis or midcavity diameter >35mm
- •Lactate greater than 3 mmol/L
- •Urine output < 0.5 ml/kg/hour
- •Age > 18 years old
- •Informed consent signed by self or legally authorized representative.
排除标准
- •INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
- •End organ failure defined as: hepatic total bilirubin >5 mg/dL based on lab data within 24 hours prior to transseptal ECMO initiation; renal creatinine >4 mg/dLbased on lab data within the 24 hours prior to transseptal ECMO initiation
- •Evidence of acute neurologic injury
- •Active infection defined as two of the following WBC >12,500, positive blood culture, fever
- •RA thrombus
- •Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia
- •Right heart failure from isolated pulmonary embolism
- •Right heart failure from coronary artery disease or from left heart failure (WHO Type 2)
- •Congenital forms of pulmonary hypertension such as tetralogy of fallot or pulmonary vein stenosis.
研究组 & 干预措施
Lung transplant patients
Experimental
Subjects will be those who are on the transplant list and progress to needing right ventricle (RV) support
干预措施: Protek Solo Transseptal Cannula (Device)
结局指标
主要结局
Survival until transplant
时间窗: 3 weeks
Number of subjects to survive between placement of cannula and lung transplant.
次要结局
- Number of subjects to experience adverse events(2 months)
- Extra-corporeal membrane oxygenation (ECMO) support(2 months)
- Dialysis(2 months)
- Hospital Discharge(2 months)
研究者
研究点 (1)
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