Lung Transplant Candidates Transseptal ECMO with the Protek Solo Cannula with Right Heart Failure from Pulmonary Hypertension

Overview

About this study

The purpose of this study is to determine if transseptal ECMO can bridge PH-RVF patients to lung transplant safely.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Patients that are listed for lung transplantation and have:
    • PH defined as:
      • *Previous treatment or on treatment with PH medications;
      • Pulmonary artery pressures > 50% of systemic pressures.
    • Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1).
    • 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 dobutamine > 10 ug/kg/min or equivalent for >15 minutes (120 minutes for milrinone) and/or administration of > 1 inotrope or vasopressor medication.
    • 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 ii. an RV diameter at base > 42mm;
        • RV short-axis or midcavity diameter >35mm.
    • Age > 18 years old.
    • Signed informed consent.

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.   

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/28/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Ian Makey, M.D.

Contact us for the latest status

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available