View clinical trials related to Heart Defects, Congenital.
Filter by:Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a variety of clinical situations including brain injury can protect the brain. The purpose of this research study is to determine whether progesterone administered during the 3rd trimester of pregnancy (24-39 weeks) to pregnant women protects the brain of unborn babies with CHD and improves their neurodevelopmental outcomes after heart surgery.
Tranexamic acid is a relatively safe medicine that is used to help the body develop clots and slow down bleeding after large surgeries. While it has already been shown to work well in adults and older children, there is no information on whether it works, and how it works in children younger than 6 months old. The goal of our study is to try and understand whether and how tranexamic acid works in children younger than 6 months old who are having open heart surgery. We plan to study tranexamic acid by testing its effect when compared with a placebo. The investigators will use a method called randomization - which means patients who agree to be in the study will be entered into a computer. The computer will randomly assign them to either receive the medicine or the placebo. We will then compare effects on the 2 groups of patients. Our goal is to have 50 patients in each group, or 100 patients total. We will not know whether patients receive tranexamic acid or placebo until we review the data collected at the end of the study. Tranexamic acid is usually given to patients in the operating room during open heart surgery. During open heart surgery patients require cardio-pulmonary bypass which is a machine that replaces the function of the heart and lungs for a short period of time. This allows surgeons to do surgery on the heart itself without having to worry about it moving during the operation. The bypass machine has lots of tubes to carry the blood around it. When blood comes into contact with the tubing it has a tendency to clot. To prevent this patients are given a blood thinner called heparin. Although heparin prevents clotting in the bypass machine, it can also increase the risk of bleeding when the surgery is over. To reduce this risk patients are given another medicine at the completion of surgery called protamine to try and reverse the effect of the blood thinner, heparin. Even so bleeding remains a significant problem, especially for babies after open heart surgery. Being on the bypass machine and having a lot of suture (stitches) lines increase that risk. In addition, the bypass machine affects the function of platelets, the main component of the body's clotting system. We often have to replenish blood products after surgery to try and stop the bleeding. Some centers, including we , have used the medicine tranexamic acid to try and help with bleeding after surgery. There have been other studies that show it helps with fibrinolysis, which is another important part of the body's clotting system. However, that part of the clotting system is not well developed in infants and therefore likely does not play an important role in preventing bleeding in that age group. As such, it may be that tranexamic acid impacts platelet function as well, and it is that effect that helps decrease post-operative bleeding in infants younger than 6 months. This has not been previously studied. In order to study the effect that tranexamic acid has on platelets the investigators are proposing the investigators' research trial. The investigators plan to randomize patients to either receive tranexamic acid or placebo in the operating room as described above. The investigators will then draw a small amount of blood from each patient (total of approximately 1 tablespoon) and send it to a special lab for testing of platelet function. The lab test will help us understand whether the platelets function better when patients receive tranexamic acid instead of placebo. The investigators will also be monitoring other outcomes related to platelet function. These will include how much bleeding patients have after surgery when they are in the intensive care unit, and how much blood products they require to treat that bleeding. The investigators will also monitor labs that are checked routinely in all patients after open heart surgery. The investigators will also track how long it takes each patient to get off the ventilator and how long they spend in the ICU after surgery. All of this data will help us understand whether tranexamic acid makes a positive impact on outcomes after open heart surgery in infants less than 6 months old. The current standard of care is quite variable within our institution as well as at other institutions. Some anesthesiologists use tranexamic acid while others elect not to. There is no definitive guideline to its current use. The dosing differs from center to center, and there are some centers that do not use it at all. The investigators' hope is that the results of this study will help us understand the role tranexamic acid plays in preserving the function of platelets after open heart surgery in young infants, and whether that impact translates into improved outcomes for those patients. Based on the results of our research we hope to develop definitive guidelines for the use of tranexamic acid in the population of infants <6 months old undergoing open heart surgery.
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.
High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.
Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. Therefore, the investigators attempt to find out independent risk factors regarding perioperative variables.
Viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. Therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. The investigators also attempt to evaluate the correlation between ROTEM parameters, platelet count, and results of conventional coagulation test results.
Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to realize a record that reflects a national overview of the role of cardiac catheterization in patients with congenital heart disease in hospitals distributed by geographic density of each region of Brazil.
the first purpose of the study is to determine the adaptative mechanisms of right ventricle (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels
The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after repair. Most common protocols recommend heparin infusions after surgery with transition to oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart surgery requiring long-term antiplatelet therapy include those undergoing shunt placement for single-ventricle palliation or establishment of pulmonary blood flow, valve replacements, or coronary artery manipulation. Post-operative thrombosis after congenital heart surgery is rare, but thrombosis can result in death. The routine use of aspirin in these patients is intended to prevent the potentially catastrophic consequences of thrombosis. However, there is no routine clinical assessment of the platelet inhibitory effect of aspirin; nor have there been any prospective studies to assess the effectiveness of aspirin's antiplatelet effect in children after congenital heart surgery. No data exists to suggest that the first dose of aspirin transition from heparin infusion is either sufficient or insufficient in its antiplatelet effect. In this study, the investigators will evaluate the effectiveness of the first aspirin dose in its antiplatelet effects after surgery for congenital heart disease. Degree of antiplatelet effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping study analysis. Thromboelastography is a clinical laboratory method of assessing whole blood hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most commonly used in patients at risk for bleeding or thrombosis and also to monitor antiplatelet therapies (such as aspirin). The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help support the current practice of empiric aspirin therapy to prevent post-operative thrombosis in children after congenital heart surgery.
This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).