View clinical trials related to Congenital Abnormalities.
Filter by:This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.
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 purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).
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.
Context: Chest wall deformities in children are relatively common. One such deformity, known as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these abnormalities - present in approximately 1 out of every 400-1000 births. This deformity is often a cosmetic problem for affected individuals. When severe, PE can also be associated with cardiopulmonary compromise. Treatment of PE involves surgical correction. There are several potential methods for correcting PE. In the past the most common repair involved an open procedure which involves excision and reshaping of the ribcage. More recently a minimally invasive procedure has been adopted involving the placement of a stainless steel or titanium bar underneath the sternum to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries with it significant post-operative pain management problems. In fact, the pain issues after Nuss procedure may be more significant than after open repair. The quality of postoperative pain control in these cases has been shown to affect several measurable objective outcomes during hospitalization including capacity for deep breathing, early mobilization, ambulation, and length of hospital stay. Epidural analgesia (EA) has been one of the standard methods for managing pain in the early postoperative period after PE repair. Unfortunately severe pain may persist after the removal of an epidural catheter resulting in a difficult "transition" period just prior to discharge from the hospital. In addition reports of neurological injury after epidural analgesia for Nuss procedures have appeared. In light of these issues, many institutions have opted for alternative methods of pain control including peripheral nerve blocks, patient controlled analgesia, and wound catheters. There remains significant debate as to which pain control methodology is best. There is little consistent data available on pain control or outcomes that occur after EA is stopped. Moreover there is reluctance in any one institution to trial or randomize patients to a variety of treatment modalities. For all of these reasons, investigators are proposing participation in a multi-institutional data sharing project concerning the repair of EA in which participating centers will collaborate to better understand the outcomes of perioperative care for patients undergoing correction of this problem.
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management. The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%). As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.
Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood loss. When used intravenously, it has been shown to safe, efficacious, and effective in reducing transfusion requirements and blood loss in spine surgeries. We want to evaluate the effect of using TXA topically and intravenously to see if it further reduces blood loss in children undergoing major surgery compared to IV TXA only
US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate® therapy at any time during the pregnancy.
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).