๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria
Patients that are listed for lung transplantation and have:
* PH defined as:
* Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) โฅ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) \< 15 mm Hg, and pulmonary vascular resistance (PVR) โฅ 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) โฅ 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:
1. central venous pressure (CVP) \> 15 mm Hg
2. global RV dysfunction on echocardiography defined as one of the following:
1. a tricuspid annular plane systolic excursion score of \<14mm
2. an RV diameter at base \>42mm
3. RV short-axis or midcavity diameter \>35mm
* Lactate greater than 3 mmol/L
* Urine output \< 0.5 ml/kg/hour
* Age \> 18 years old
* BMI \<35
* Informed consent signed by self or legally authorized representative.
Exclusion Criteria
* 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.
๐
What it tests
- Protek Solo Transseptal Cannula
Mayo Clinic in Florida
Jacksonville, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.