Active clinical trials for "Heart Defects, Congenital"

Neonates, children with single ventricle congenital heart disease, and those undergoing multiple complex cardiac surgeries are at high risk of increased perioperative blood loss, and blood product transfusions. In addition, some of these patients will present an increased risk of postoperative thromboembolic complications. For a long time, bleeding management has been based on the empiric administration of different blood products (e.g. platelet concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic agents, and surgical manipulation. Recently, the use of viscoelastic tests (e.g. thromboelastography (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better assessment of perioperative coagulopathy, and a more 'rational' treatment of bleeding. While TEG and ROTEM record the viscoelastic properties of whole blood by measuring mechanical impedance and related changes during clot formation, T2MR, a miniaturized, magnetic resonance-based diagnostic platform, measures how water molecules react in the presence of magnetic fields to evaluate a broad range of hemostasis measurements. In this study, we will prospectively collect demographic data, surgical characteristics, the amount of perioperative bleeding and blood product transfusion, results of laboratory assays, and postoperative outcomes (30-day follow-up or until discharge), with the aim to assess our current practice, and develop an algorithm-based approach for the administration of targeted blood product and pro-coagulant therapies. Our goals are: the reduction of blood product utilization, the reduction of the incidence of massive bleeding and postoperative thrombosis.

The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is connected to the inferior vena cava and the other end to the pulmonary artery confluence. Xeltis developed a biodegradable prosthesis, the Xeltis Vascular Graft Model COR-VG-001, to be used as an extracardiac conduit between right atrium and the pulmonary arteries. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. The Xeltis Vascular Graft Model COR-VG-OO is specifically designed to enhance the Fontan surgery outcome by reducing synthetic material related complications and improving hemodynamic characteristics.

The purpose of this study is to test the hypothesis that treating PAH-CHD patients preoperatively with PAH drugs and keeping them on treatment for six months after surgery reduces the risk of immediate postoperative death and the risk of residual PAH at six months following operation to <10%.

Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. The investigators goal is to see if this shows problems developing sooner than usual. The investigators do not know at this time if they can improve the blood supply to the vital organs. The investigators main aim is to see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug Administration (FDA). The investigators will also follow the progress of recovery after surgery in the Cardiac Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome for children.

The objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their parents, and to determine whether this intervention results in improved self-management skills (e.g., renewing medication prescriptions), teens having greater knowledge of their heart condition, and more teen and parent satisfaction with services. The results of this study will form the basis for a website that in turn may serve as an additional means of providing transition interventions. The results of this study may also be applicable to youth with other special health care needs.

Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself. In general, the more intense their inflammatory response, the more critically ill they are following surgery. These children routinely require large numbers of blood transfusions during and following surgery as part of their medical management that adds to their heightened inflammatory state. Whether additional steps to "wash" blood products and remove the substances contributing to post-transfusion inflammation will limit this response, and improve the health of children following open heart surgery, remains to be studied. Aims: To compare the inflammatory response in children having open heart surgery who receive washed versus unwashed blood transfusions. Methods: We will randomly assign children having open heart surgery to one of two groups: group 1 will receive blood transfusions per the current standard of care, group 2 will receive blood transfusions that have been washed in addition to the current standard of care. We will then use blood tests to measure the inflammatory response in children of each group. We will compare the results to determine whether washing blood transfusions decreases inflammation and post-operative complications following open heart surgery. Conclusion: We believe that washing blood transfusions given to children following open heart surgery will decrease their inflammatory response and improve their overall health.

Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.

The investigators hypothesize that intermittent bolus doses of morphine and midazolam can provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus infusions while using smaller total doses of both medications. The investigators will randomize patients to receive either morphine/midazolam as needed intermittently or morphine/midazolam drips plus intermittent doses to be received as needed. Pain scores will be recorded and total medications given will be recorded.

Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows, through an oesophageal catheter, to record the electrical activity of the diaphragm and thereby synchronize breaths from the ventilator on the inspiratory efforts of the child. Moreover, the pressure support delivered by the ventilator may be proportional to the diaphragmatic effort developed by the child. This mode, associated with the interface Miniflow®, could increase the comfort of the child by allowing a more efficient synchronization and reducing its respiratory work. To our knowledge, this ventilation mode with this interface has not been evaluated in the postoperative period of cardiac surgery in the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory mode and evaluate its influence on ventilatory parameters of this category of infants.

OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II. Determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified Fontan procedure. III. Evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified Fontan procedure.