Lung Transplant Techniques for Lung Transplant
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Single lung transplant, Multiorgan transplant, Re-transplant, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Off-pump lung transplantation and Venoarterial ECMO for lung transplant?
Research suggests that using venoarterial extracorporeal membrane oxygenation (VA ECMO) during lung transplants may be more effective than off-pump support for patients without severe lung blood pressure issues. VA ECMO is increasingly used and may offer better outcomes compared to traditional methods.
12345How does the treatment Off-pump lung transplantation with Venoarterial ECMO differ from other treatments for lung transplantation?
Off-pump lung transplantation with Venoarterial ECMO (VA ECMO) is unique because it avoids the use of cardiopulmonary bypass, which can reduce the risk of bleeding and primary graft dysfunction. This approach also allows for better chest wall function and less postoperative pain compared to traditional methods that use extracorporeal circulation.
13467Eligibility Criteria
This trial is for people who need both lungs replaced and can have surgery with or without a heart-lung machine (ECMO), as decided by their surgeon. They must have a certain level of blood pressure in the lungs to qualify. It's not for those needing only one lung, multiple organs, re-transplants, or who had major lung surgeries before.Inclusion Criteria
Mean pulmonary artery pressure < or = 35 mmHg
I have received a transplant for both of my lungs.
My surgeon thinks I can have surgery without using a heart-lung machine.
Exclusion Criteria
My organ donor died of cardiac failure.
I plan to use a machine to help my heart and lungs after surgery.
I have had a single lung transplant.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo bilateral lung transplantation using either off-pump or VA ECMO techniques
Intraoperative plus the first 24 hours in the ICU
Follow-up
Participants are monitored for safety and effectiveness, including incidence of PGD, mortality, and other complications
90 days
Long-term follow-up
Participants are monitored for long-term outcomes such as transplant rejection and overall survival
Up to 90 days or discharge from the index hospitalization
Participant Groups
The study compares two ways to do lung transplants: 'off-pump' without using ECMO and using venoarterial ECMO during the procedure. The main focus is on which method leads to fewer complications with the new lungs starting to work ('primary graft dysfunction').
2Treatment groups
Active Control
Group I: Off-Pump Bilateral Lung TransplantationActive Control1 Intervention
Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care
Group II: Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung TransplantationActive Control1 Intervention
Subjects will receive VA ECMO technique for lung transplantation as part of standard of care
Off-pump lung transplantation is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Off-pump lung transplantation for:
- End-stage lung disease
- Cystic fibrosis
- Bronchiectasis
- Pulmonary hypertension
- Emphysema
- Pulmonary fibrosis
🇺🇸 Approved in United States as Off-pump lung transplantation for:
- End-stage lung disease
- Cystic fibrosis
- Bronchiectasis
- Pulmonary hypertension
- Emphysema
- Pulmonary fibrosis
🇨🇦 Approved in Canada as Off-pump lung transplantation for:
- End-stage lung disease
- Cystic fibrosis
- Bronchiectasis
- Pulmonary hypertension
- Emphysema
- Pulmonary fibrosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
Massachusetts General HospitalBoston, MA
Mayo Clinic FloridaJacksonville, FL
Temple University HospitalPhiladelphia, PA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
A new technique for double lung transplantation. "Bilateral single lung" transplantation. [2004]Two techniques are currently practiced to achieve bilateral lung transplantation for the treatment of patients with end-stage pulmonary disease associated with infection: heart-lung transplantation, which is illogical, and double lung transplantation by the Toronto technique, which is difficult and entails tracheal complications. After our short experience with single lung transplantation without any bronchial problems, we have performed three double lung transplantations by a new technique, "bilateral single lung" transplantation. After a sternal bithoracotomy, first one lung was transplanted and then the other, without cardiopulmonary bypass. This bilateral single lung transplantation provides all the advantages of single lung transplantation and is particularly recommended for use in patients with severe pleural adhesions.
Intraoperative Support for Primary Bilateral Lung Transplantation: A Propensity-Matched Analysis. [2023]Single-center studies support benefits of venoarterial extracorporeal membrane oxygenation (VA-ECMO) as a method of intraoperative support. Propensity-matched data from a large cohort, however, are currently lacking. Therefore, our goal was to compare outcomes of intraoperative VA-ECMO and cardiopulmonary bypass (CPB) during bilateral lung transplantation (LTx) with a propensity analysis.
Textbook outcome in lung transplantation: Planned venoarterial extracorporeal membrane oxygenation versus off-pump support for patients without pulmonary hypertension. [2023]Planned venoarterial extracorporeal membrane oxygenation (VA ECMO) is increasingly used during bilateral orthotopic lung transplantation (BOLT) and may be superior to off-pump support for patients without pulmonary hypertension. In this single-institution study, we compared rates of textbook outcome between BOLTs performed with planned VA ECMO or off-pump support for recipients with no or mild pulmonary hypertension.
Circulatory support during lung transplantation. [2021]Lung transplantation can be performed off-pump, with sequential one-lung ventilation, or using mechanical circulatory support (MCS). MCS can either be in the form of cardiopulmonary bypass (CPB) or veno-arterial or veno-venous extracorporeal membrane oxygenation (VA ECMO or VV ECMO).This article reviews the indications, benefits and limitations of these different techniques and evaluates their effect on outcomes.
Comparison of mechanical cardiopulmonary support strategies during lung transplantation. [2022]Lung transplantation outcomes are influenced by the intraoperative mechanical cardiopulmonary support strategy used. This surgery was historically done either on cardiopulmonary bypass (CPB) or off pump. Recently, there has been increased interest in intraoperative support with veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO). However, there is a lack of consensus on the relative risks, benefits and indications for each intraoperative support strategy.
Vascular access for extracorporeal life support: tips and tricks. [2022]In thoracic surgery, extracorporeal life support (ECLS) techniques are performed to (I) provide a short to mid term extracorporeal mechanical support; (II) realize the gas exchanges; and (III)-depending the configuration of the circuit-substitute the failed heart function. The objective of this review is to describe the rational of the different ECLS techniques used in thoracic surgery and lung transplantation (LTx) with a specific attention to the vascular access. Venovenous extracorporeal membrane oxygenation (VV ECMO) is the most common ECLS technique used in thoracic surgery and represents the best strategy to support the lung function. VV ECMO needs peripheral vascular access. The selection between his double-site or single-site configuration should be decided according the level of O2 requirements, the nosological context, and the interest to perform an ECLS ambulatory strategy. Venoarterial (VA) ECMO uses peripheral and/or central cannulation sites. Central VA ECMO is mainly used in LTx instead a conventional cardiopulmonary bypass (CPB) to decrease the risk of hemorrhagic issues and the rate of primary graft dysfunction (PGD). Peripheral VA ECMO is traditionally realized in a femoro-femoral configuration. Femoro-femoral VA ECMO allows a cardiocirculatory support but does not provide an appropriate oxygenation of the brain and the heart. The isolated hypercapnic failure is currently supported by extracorporeal CO2 removal (ECCO2R) devices inserted in jugular or subclavian veins. The interest of the Novalung (Novalung GmbH, Hechingen, Germany) persists due to his central configuration indicated to bridge to LTx patients suffering from pulmonary hypertension. The increasing panel of ECLS technologies available in thoracic surgery is the results of a century of clinical practices, engineering progress, and improvements of physiological knowledges. The selection of the ECLS technique-and therefore the vascular access to implant the device-for a given nosological context trends to be defined according an evidence-based medicine.
Off-Pump Bilateral Lung Transplantation via Median Sternotomy: A Novel Approach With Potential Benefits. [2019]The clamshell incision is the standard approach for bilateral lung transplantation. There is limited experience with bilateral lung transplantation via median sternotomy, and the use of cardiopulmonary bypass seems to be mandatory in all cases while accepting the potential disadvantages of the extracorporeal circulation. We describe a novel approach for bilateral lung transplantation as an off-pump technique via median sternotomy. This approach has the potential to combine the advantages of median sternotomy with less postoperative pain, better chest wall function, and reduced risk of primary graft dysfunction and bleeding complications.