PREDICTORS OF SPONTANEOUS CEREBRAL AVM HEMORRHAGE

自发性脑动静脉畸形出血的预测因素

• 批准号: 6187282
• 负责人: WILLIAM L YOUNG
• 金额: $ 43.72万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 2002-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6187282
• 关键词: brain circulation; cerebral hemorrhage; cerebrovascular disorder diagnosis; cerebrovascular imaging /visualization; cerebrovascular surgery; clinical research; disease /disorder proneness /risk; hemodynamics; human subject; mathematical model; postoperative complications; prognosis

The primary reason to treat cerebral arteriovenous malformations (AVMs) is the prophylaxis against intracranial hemorrhage (ICH). However, treatment of AVMs by surgery, embolization and/or radiosurgery carries a significant risk. Newer evidence suggests that distinct natural history sub-groups are present under the general heading of AVM . This project represents a three-pronged plan of research. The accomplishment of these aims could bring to treating physicians and surgeons a rational basis for decreasing morbidity and more cost-effective decision-making in patients with AVMs. Specific Aim I is a single-center-based study of hemorrhagic risk to (Ia) define factors for spontaneous ICH and to test the hypothesis that high feeding artery pressure and exclusively-deep venous drainage are the strongest predictors for hemorrhage; and to (Ib) extend the ongoing prospective study of new or recurrent hemorrhage after initial presentation. We will test the hypothesis that subsequent AVM hemorrhage is related to initial hemorrhagic presentation of the disease. This aim will further define hemorrhagic presentation as a risk, factor for subsequent bleeding, and also establishes the critical assumption for (Ia) that recurrent ICH is related to the pathophysiology of ICH at initial presentation. Specific Aim II is a population-based approach to study spontaneous AVM hemorrhage to broaden the applicability of our findings under Specific Aim Ib. In this New York Islands AVM study, participating institutions include those from Manhattan, Staten Island, Queens and Brooklyn; and Nassau and Suffolk Counties on Long Island (population of aprox. 8,800,000 by 1996 estimates). For Specific Aim III we propose to develop and test the feasibility of a risk-based allocation algorithm (also called assured allocation) for use in clinical trials using information gained from Specific Aims I and II. This novel alternative to a randomized clinical trial, successfully tested in retrospective studies, has not been previously used in clinical interventional trials. We expect to demonstrate, by development of an statistical model, that a risk-based allocation method is a viable strategy as the basis for constructing a multicenter (possibly multinational) clinical trial.

治疗脑动静脉畸形（AVM）的主要原因 是预防颅内出血（ICH）的有效方法。然而，在这方面， 通过手术、栓塞和/或放射外科手术治疗AVM， 重大风险 新的证据表明， 在反车辆地雷的总标题下列出了历史分组。 这 该项目是一个三管齐下的研究计划。 的完成而 这些目标可以为治疗内科医生和外科医生带来一个合理的 降低发病率和作出更具成本效益的决策的基础 在AVM患者中。 特定目的I是一项单中心研究， (Ia)定义自发性ICH的因素，并检验以下假设： 高供血动脉压和单纯深静脉引流 出血的最强预测因子;以及（Ib）延长正在进行的 首次治疗后新发或复发性出血的前瞻性研究 演示文稿. 我们将测试后续AVM的假设 出血与初始出血表现有关， 疾病 这一目标将进一步定义出血性表现为一种 风险，后续出血的因素，也建立了关键的 假设（Ia）复发性ICH与病理生理学相关 ICH在最初的介绍。 Specific Aim II是研究自发性AVM的基于人群的方法 出血，以扩大我们的研究结果在特定 阿姆湾 在这项纽约群岛AVM研究中，参与 机构包括那些来自曼哈顿，斯塔顿岛，皇后区和 布鲁克林;长岛的拿骚县和萨福克县（ aprox. 1996年估计为8，800，000人）。 对于具体目标III，我们建议开发和测试以下可行性： 基于风险的分配算法（也称为保证分配） 用于临床试验，使用从特定目的获得的信息 一期及第二期 这是随机临床试验的新选择， 在回顾性研究中成功测试，以前没有 用于临床干预试验。 我们希望证明，通过 开发一个统计模型，即基于风险的分配方法 是一个可行的策略，作为构建一个多中心的基础， （可能是多国）临床试验。