Clinical Trial Studying Treatment of COPD Taking Place in Shreveport

Landmark trial looking for potential candidates

SHREVEPORT, La. (May 8, 2019) – LSU Health Shreveport physicians are currently leading the VENT-AVOID Trial at Ochsner LSU Health Shreveport Academic Medical Center. The VENT-AVOID Trial is a pivotal clinical trial sponsored by ALung Technologies (Pittsburgh, Pa.) that is the world’s first trial of extracorporeal carbon dioxide removal (ECCO2R) for treating patients with COPD exacerbations. Ochsner LSU Health Shreveport is the only VENT-AVOID Trial site in Louisiana, and is one of 31 trial locations in the United States. The Principal Investigator for the site is Dr. Keith Scott, Professor of Medicine, Pediatrics, and Anesthesiology, and Chief of the Section of Pediatric Pulmonary Medicine, at LSU Health Shreveport.

The VENT-AVOID Trial is a prospective, multi-center, randomized, controlled, two-arm trial of the Hemolung Respiratory Assist System (Hemolung RAS), an investigational medical device that provides low-flow extracorporeal CO2 removal, or ECCO2R, for the treatment of adults with acute hypercapnic respiratory failure due to a severe exacerbation of chronic obstructive pulmonary disease (COPD). The VENT-AVOID Trial is a landmark trial of ECCO2R for treating patients with COPD exacerbations.

The Hemolung RAS is a dialysis-like device that provides extracorporeal lung support using a 15.5 French central venous catheter for patients experiencing acute hypercapnic respiratory failure. The VENT-AVOID Trial will evaluate the safety and efficacy of the Hemolung RAS in providing ECCO₂R as an alternative or supplement to invasive mechanical ventilation for patients experiencing severe COPD exacerbations. The trial is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration.

Eligible patients will be randomized to one of two treatment arms. Patients in the first treatment arm (the Investigational Arm) will receive lung support with the Hemolung RAS plus standard-of-care mechanical ventilation. Patients in the second treatment arm (the Control Arm) will receive standard-of-care mechanical ventilation alone. The primary outcome measure for the trial is the number of ventilator-free days measured from the time the patient is randomized to a treatment arm through 60 days post-randomization.

ALung announced today that a major milestone has been reached in the U.S. based VENT-AVOID clinical trial. Following its first scheduled review of safety data from the initial 31 subjects enrolled, the independent Data and Safety Monitoring Board (DSMB) of the VENT-AVOID trial recommended continuation of the trial without modification.
According to the American Lung Association, COPD affects 30 million Americans and is the third leading cause of death in the United States behind cancer and heart disease. Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients.

For patients with severe exacerbations, high levels of carbon dioxide can result in respiratory failure and the need for intubation and mechanical ventilation as life saving measures. ECCO2R therapy with the Hemolung RAS allows carbon dioxide to be removed from the blood independently of the lungs with the aim of facilitating the avoidance or reduction of intubation and invasive mechanical ventilation.

For more information about the VENT-AVOID Trial, visit https://clinicaltrials.gov/ct2/show/NCT03255057. Interested participants can also email lscott2@lsuhsc.edu or ksmit9@lsuhsc.edu with LSU Health Shreveport.

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MEDIA NOTES:
ALung photos and media kit can be found at www.alung.com/media-kit/.
For more information about ALung and the Hemolung RAS, visit www.alung.com.

For more information about research at LSU Health and to schedule an interview with Dr. Scott to learn more about the VENT-AVOID Trial, please contact:

Lisa Babin, Executive Director of Public Affairs & Communication
Office: 318-675-8769 | Cell: 318-458-0166
lbabi6@lsuhsc.edu

Megan Strecker, Public Relations Coordinator
Office: 318-675-8789 | Cell: 770-595-3052
mstrec@lsuhsc.edu

For questions relating to the hospital, Ochsner LSU Health Shreveport Academic Medical Center, please contact:

Tina Martinez
318-840-5522
tina.martinez@ochsner.org