U01HL163298

Catch: Creating Access to Transplant for Candidates Who Are High Risk - Project Summary

Today, lung transplantation for patients with end-stage lung disease has become increasingly standardized around the world, thanks to decades of international collaboration and partnership. As a result, more patients can receive a life-saving procedure and benefit from vastly improved survival and quality of life.

However, access to lung transplant remains particularly variable for three categories of high-risk patients: 1) highly sensitized patients; 2) patients requiring extracorporeal membrane oxygenation support as a bridge to transplant (ECMO-BTT); and 3) patients with acute respiratory distress syndrome (ARDS, including those with COVID-19-associated ARDS). Because these patients are at high risk for complications and historically understudied, there are no clear guidelines for their treatment. As a result, they are uniquely disadvantaged: receiving a transplant largely depends on their program's willingness to accept the risk of transplant without sufficient data to inform how it can be optimally and safely performed.

Programs, therefore, differ in the selection and management of these patients, creating significant disparities and variation in care across centers, ultimately to the detriment of the transplant candidate.

With support from the NIH Lung Transplant Consortium, we propose the formation of Catch: Creating Access to Transplant for Candidates Who Are High Risk, with the goal to improve access and outcomes for these patients in need. The four lung transplant programs that comprise Catch—University Health Network, University of Florida, Columbia University, and Brigham and Women's Hospital—collectively perform over 400 lung transplantations per year, and each has extensive but differing experience in managing these patients.

Our Catch study hypothesis is that our individual management strategies significantly impact high-risk candidates' likelihood of receiving a transplant and their post-transplant outcomes. Through prospective cohort studies, we aim to devise an optimal and united strategy that addresses the specific unmet needs of these high-risk patients.

Our team has been carefully assembled based on scientific merit and strategic collaboration, representing multidisciplinary strengths in thoracic surgery and lung transplant pulmonology that will complement our recognized research leadership. We have extensive experience in successful project management for large multi-site projects, and our expertise in developing standardized protocols and consensus documents will help to maximize the potential across all transplant centers.

Ultimately, as key opinion leaders in a field that actively looks to us for guidance, our Catch project outcomes are strongly positioned to have an immediate transformative impact by standardizing the field and ensuring that every patient in need of a lung transplant can receive one.

University Health Network

THE DIVISION OF LUNG DISEASES SUPPORTS RESEARCH AND RESEARCH TRAINING ON THE CAUSES, DIAGNOSIS, PREVENTION, AND TREATMENT OF LUNG DISEASES AND SLEEP DISORDERS. RESEARCH IS FUNDED THROUGH INVESTIGATOR-INITIATED AND INSTITUTE-INITIATED GRANT PROGRAMS AND THROUGH CONTRACT PROGRAMS IN AREAS INCLUDING ASTHMA, BRONCHOPULMONARY DYSPLASIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CYSTIC FIBROSIS, RESPIRATORY NEUROBIOLOGY, SLEEP AND CIRCADIAN BIOLOGY, SLEEP-DISORDERED BREATHING, CRITICAL CARE AND ACUTE LUNG INJURY, DEVELOPMENTAL BIOLOGY AND PEDIATRIC PULMONARY DISEASES, IMMUNOLOGIC AND FIBROTIC PULMONARY DISEASE, RARE LUNG DISORDERS, PULMONARY VASCULAR DISEASE, AND PULMONARY COMPLICATIONS OF AIDS AND TUBERCULOSIS. THE DIVISION IS RESPONSIBLE FOR MONITORING THE LATEST RESEARCH DEVELOPMENTS IN THE EXTRAMURAL SCIENTIFIC COMMUNITY AS WELL AS IDENTIFYING RESEARCH GAPS AND NEEDS, OBTAINING ADVICE FROM EXPERTS IN THE FIELD, AND IMPLEMENTING PROGRAMS TO ADDRESS NEW OPPORTUNITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Canada

Foreign

Lung Transplant Consortium - Clinical Centers (U01 - Clinical Trial Not Allowed) (RFA-HL-22-002)

Amendment Since initial award the total obligations have increased 294% from $404,700 to $1,592,826.