Clinical Trials

As one of the nation’s leading academic programs, University Health System, in partnership with UT Health San Antonio, is helping to develop new and better treatment options for pediatric and congenital heart disease.

Patients have the advantage of accessing one of the clinical trials occurring at our Heart Center. Congenital heart defect clinical trials are not right for every patient, and it’s important for families to understand their options and ask questions. Before you are asked to make any decisions, we will take the time to answer any questions and discuss all risks and benefits of the participation.

Contact us for more information about current clinical trials that are actively recruiting. You can also find more information about clinical trials from the National Heart, Lung, and Blood Institute and the searchable database of clinical trials maintained by the National Library of Medicine at the National Institutes of Health.

Sternal Wound Infection Project

Initiated in 2011, we researched sternal wound infections following pediatric cardiac surgery through a survey study of all programs across the United States. The study, which was published in the Annals of Thoracic Surgery, revealed very little consistency in the approaches made to limit infections. Our group then embarked upon creating a data-driven protocol for the prevention of sternal wound infections and implemented it within our program from 2011-2013. We found that the implementation of the protocol decreased our incidence of sternal wound infections. Our results were published in the World Journal for Pediatric and Congenital Cardiac Surgery in 2013. Subsequently, we became the lead institution in a 2-year prospective, multi-institutional study, involving 10 programs looking at a uniformed approach towards decreasing the incidence of sternal wound infections. This study is in conjunction with the Society of Thoracic Surgeons National Database. Our data collection has just been completed and we are in the process of data analysis prior to formal presentation and manuscript submission.

Fontan Protocol

In June of 2015, our program initiated a protocol for patients undergoing third-stage palliation for single ventricle disease (the Fontan procedure). This operation is known to be associated with prolonged hospital stays secondary to pleural effusions. Our team used a data-driven approach to create a formalized protocol for all patients receiving the Fontan procedure, which included specific surgical intensive care and pharmacologic therapies. Since the initiation of the protocol, our programmatic lengths of stay for a Fontan Procedure have decreased an average of 66 percent.

Early Extubation Protocol

In December of 2015, our program initiated an early extubation strategy for patients undergoing congenital heart surgery. More specifically, we are tracking our ability to extubate a patient in the operating room versus the first 6 hours of arrival at PCCU. We used a well-defined subset of patients, and constructed this protocol using parameters defined by other studies. However, we submit that this particular approach is more encompassing than previously published reports. It is our belief that we must evaluate the safety of such an approach and if deemed a safe therapeutic initiative, to further evaluate the ability to extubate patients earlier.