PREVENTION OF DVT IN STROKE REHABILITATION

中风康复中 DVT 的预防

• 批准号: 2719717
• 负责人: RICHARD L HARVEY
• 金额: $ 5.6万
• 依托单位: REHABILITATION INSTITUTE RESEARCH CORP
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-28 至 1999-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2719717
• 关键词: angiocardioultrasonography; blood coagulation; cardiovascular disorder prevention; cerebral hemorrhage; chemoprevention; clinical research; clinical trials; comorbidity; disease /disorder proneness /risk; drug administration routes; functional ability; health care cost /financing; heparin; human subject; human therapy evaluation; mathematical model; nervous system disorder; outcomes research; rehabilitation; stroke; venous thrombosis

The clinical importance of medical complications in stroke rehabilitation is well recognized. However, the epidemiology, management and prevention of rehabilitation related medical complications and comorbidities receive little research attention in physiatry. Venous thromboembolism in stroke rehabilitation remains a serious problem, yet rigorous studies of risk, prevention, outcome and functional impact are lacking. This three-center trial will examine both the clinical and epidemiological aspects of deep vein thrombosis (DVT) prevention in the stroke rehabilitation population. The clinical study is a randomized placebo controlled trial of unfractionated heparin (100 units/kg subcutaneously bid) for prevention of DVT. The medication trial will determine if an additional 28 days of low-dose heparin therapy beyond the first two-weeks after stroke onset is superior to placebo for DVT prevention during the same time period. The main outcome of DVT will be identified by clinical examination and serial venous duplex ultrasound measured weekly and one month after discontinuation of the trial medication. The epidemiological study will use multivariate logistical techniques to identify potential risk factors for DVT including demographic characteristics, medical comorbidity, severity of neurological impairment (NIH stroke scale and Fugl-Meyer score), functional disability (FIMSM instrument) and level of plasma coagulation activity (prothrombin fragment 1+2, thrombin- antithrombin complex and D-dimer). A pretrial research team consisting of the principle investigator, a research assistant and a nurse coordinator will be assembled. Goals of the one-year clinical trial development phase include finalizing the research design and protocol, development of research database, establishing a plan for statistical and interim analyses, coordinate pharmacy and blood flow services between centers and standardize plasma tests of coagulation activity. An annual subject pool of over 600 stroke rehabilitation patients from three centers will be available to participate in the three-year formal trial. A research study advisory council consisting or clinicians, researchers, an ethicist and two stroke survivors will oversee the development and implementation of the clinical trial. This clinical trial will determine the efficacy of low-dose heparin for DVT prevention during stroke rehabilitation and help clinicians identify those patients most at risk for venous thromboembolic complications.

中风并发症的临床重要性 康复治疗得到了广泛认可。 然而，从流行病学来看， 康复相关医疗的管理和预防 并发症和合并症很少受到研究关注 理疗学。 静脉血栓栓塞在中风康复中仍然是一个 严重的问题，但对风险、预防、结果和 缺乏功能影响。 这项三中心试验将检查 深静脉血栓形成的临床和流行病学方面 （DVT）预防中风康复人群。 临床上 研究是普通肝素的随机安慰剂对照试验 （100 单位/公斤，皮下注射 bid）用于预防 DVT。 药物 试验将确定是否需要额外 28 天的低剂量肝素治疗 中风发作后前两周后的治疗优于 同一时期内用于预防 DVT 的安慰剂。 主要 DVT 的结果将通过临床检查和系列检查来确定 每周和一个月后进行静脉多普勒超声检查 停止试验药物。 流行病学研究将 使用多变量物流技术来识别潜在风险 DVT 的因素包括人口特征、医疗状况 合并症、神经功能障碍的严重程度（NIH 卒中量表和 Fugl-Meyer 评分）、功能障碍（FIMSM 仪器）和水平 血浆凝固活性（凝血酶原片段 1+2、凝血酶- 抗凝血酶复合物和 D-二聚体）。 审前研究小组包括 由首席研究员、研究助理和护士组成 协调员将被召集。 一年临床试验的目标 开发阶段包括最终确定研究设计和协议， 建立研究数据库，制定统计计划 和中期分析，协调药房和血流服务 各中心之间建立标准化血浆凝血活性测试。 每年有超过 600 名中风康复患者参加的主题库 三个中心将可参加为期三年的正式 审判。 由临床医生组成的研究咨询委员会， 研究人员、一名伦理学家和两名中风幸存者将监督 临床试验的开发和实施。 本临床 试验将确定低剂量肝素预防 DVT 的功效 在中风康复期间帮助临床医生识别这些患者 发生静脉血栓栓塞并发症的风险最大。