BridgeMD
New treatment option for Lung Transplant
Official title Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
ClinicalTrials.gov ID: NCT06770023
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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).
You likely can't join if
- INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating...
- End organ failure defined as: hepatic total bilirubin \>5 mg/dL based on lab data within 24 hours prior to transseptal ECMO initiation; renal...
- 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...
See the full eligibility 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:
- 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
- BMI \<35
- Informed consent signed by self or legally authorized representative.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.