Anticoagulation Post-Fontan/Closure of ASDs

Fontan 后抗凝/ASD 闭合

• 批准号: 6797829
• 负责人: BRIAN W MCCRINDLE
• 金额: $ 35.13万
• 依托单位: HOSPITAL FOR SICK CHLDRN (TORONTO)
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6797829
• 关键词: anticoagulants; cardiovascular disorder chemotherapy; cardiovascular disorder therapy; child (0-11); clinical trials; congenital heart disorder; congenital heart septum defect; cooperative study; drug screening /evaluation; heart catheterization; heart surgery; human subject; human therapy evaluation; patient oriented research; pediatrics; postoperative state

DESCRIPTION (provided by applicant) Patient-related research in heart problems in children has been of limited quality, because of lack of collaboration and emphasis on information provided in medical charts. Important problems remain controversial and unsolved. The Fontan operation is designed for patients who have only one pumping chamber, and guides blood from the major veins returning to the heart directly into the lung arteries, with the pumping chamber reserved to pump blood into the arteries of the body. Afterwards, blood flows differently and more slowly in the veins and lungs, and clots may form, which can cause strokes. The proposed study aims to determine the risk of clots and the best way to prevent them. The study will consist of a review medical charts on a large number of patients who have had Fontan to help determine the risk of clots. For patients who will have Fontan, they will be enrolled in a study where they will be randomly assigned to different types of medications to prevent clots, which will be compared. For patients who have already had the Fontan, they will be enrolled in a similar study where they will randomly assigned to either aspirin or a medication called warfarin. In both the studies, the patients will have regular check-ups and tests for a two year period to see if clots occur and which type of medicine best prevents the clots. Atrial septal defects, or holes between the two collecting chambers of the heart, can lead to heart failure and heart rhythmn problems. They can be closed with surgery, or by placing a special patch or device with a catheter. The proposed study aims to determine whether closure is better with surgery or the catheter method, and whether there are any differences in closure with different types of catheter devices. The study will review medical charts of children who have had closure of these holes, and compare surgery and catheter methods. A second part of the study will enroll children with holes which need to be closed, and randomly assign them to either surgery or the catheter method. For patients assigned to the catheter method, they will be further randomly assigned to one of two types of catheter devices. Comparisons will be made between surgery and the two catheter methods regarding the completeness of closure and complications. A further analysis will look at patient preferences and the costs for these different types of procedures, to help determine the best way to close these holes.

描述(由申请人提供) 儿童心脏问题与患者相关的研究一直有限 质量，因为缺乏合作和对所提供信息的重视 在医疗病历上。重要问题仍然存在争议和悬而未决。这个 Fontan手术是为只有一个泵房的患者设计的， 并引导血液从主要静脉返回心脏，直接进入心脏 肺动脉，保留泵室以将血液泵入 身体的动脉。之后，血液以不同的方式缓慢地流入 静脉和肺可能会形成血栓，这可能会导致中风。建议数 这项研究旨在确定血栓的风险以及预防它们的最佳方法。 这项研究将包括对大量 服用Fontan以帮助确定血栓风险的患者。对病人来说 谁将拥有方坦，他们将被登记参加一项研究，他们将在那里 随机分配到不同类型的药物以防止血栓， 将会被比较。对于已经服用Fontan的患者，他们将是 参加了一项类似的研究，他们将随机分配到 阿司匹林或一种名为华法林的药物。在这两项研究中，患者 将进行为期两年的定期检查和测试，以确定是否有血栓 以及哪种类型的药物最能预防血栓。房间隔 缺陷或心脏两个收集腔之间的空洞可能会导致 心力衰竭和心律失常的问题。它们可以通过手术关闭， 或者通过放置带有导管的特殊贴片或装置。建议进行的研究 目的是确定封堵手术和导管哪个更好 方法，以及不同类型的闭包是否有区别 导管装置。这项研究将审查患有以下疾病的儿童的病历 缝合这些孔洞，并比较手术和导尿管方法。一秒钟 这项研究的一部分将招收需要关闭洞的儿童，以及 随机将他们分配到手术或导尿管方法。对病人来说 分配到导管方法，他们将进一步随机分配到一个 两种类型的导管装置。将在手术和手术之间进行比较 关于封堵完好性的两种导管方法和 并发症。进一步的分析将着眼于患者的偏好和 这些不同类型的程序的成本，以帮助确定最佳方式 来堵住这些洞。