Using ECMO to support lung transplant patients with right heart failure from pulmonary hypertension
A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
This study is testing if a special heart-lung machine can help patients with severe right heart failure from pulmonary hypertension while they wait for a lung transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06770023 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of transseptal extra-corporeal membrane oxygenation (ECMO) as a bridge for patients suffering from right heart failure due to pulmonary hypertension while awaiting lung transplantation. It focuses on patients who have been diagnosed with either primary or secondary pulmonary hypertension and are experiencing significant right ventricular dysfunction. The intervention involves the use of the Protek Solo Transseptal Cannula to provide necessary support until a lung transplant can be performed. Results will be published regardless of the outcomes, ensuring transparency in the findings.
Who should consider this trial
Good fit: Ideal candidates for this study are patients listed for lung transplantation who have severe pulmonary hypertension and failing right ventricle function.
Not a fit: Patients who do not have pulmonary hypertension or are not candidates for lung transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a critical lifeline for patients with severe pulmonary hypertension and right heart failure, improving their chances of receiving a lung transplant.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using ECMO for bridging patients to transplant, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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) ≥ 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:
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.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ian Makey, MD — Mayo Clinic
- Study coordinator: Ian A Makey, MD
- Email: makey.ian@mayo.edu
- Phone: 9049531048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.