Spot Sign for Predicting and Treating ICH Growth (STOP IT)

预测和治疗 ICH 生长的斑点标志（停止它）

• 批准号: 8377344
• 负责人: Thomas M Hemmen
• 金额: $ 12.04万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-19 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8377344
• 关键词: Acute; Adult; Affect; Angiography; Blinded; Blood Coagulation Factor; Canada; Case Fatality Rates; Case Series; Cerebral hemisphere hemorrhage; Clinical; Code; Data; Enrollment; Extravasation; Factor VIIa; Growth; Head; Hematoma; Hemorrhage; Hemostatic Agents; Hour; Intracranial Hemorrhages; Measures; Natural History; Neurologic; Neurological outcome; Outcome; Patients; Persons; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Placebo Control; Placebos; Play; Randomized; Randomized Clinical Trials; Reading; Recombinants; Research; Research Personnel; Risk; Role; Scanning; Sensitivity and Specificity; Site; Spottings; Stroke; Symptoms; TNFRSF5 gene; Therapeutic; Time; United States; Work; X-Ray Computed Tomography; acute stroke; arm; high risk; improved; patient population; phase 2 study; primary outcome; prospective; recombinant FVIIa; stroke therapy; tool

The Spot Sign for predicting and treating ICH growth study (STOP-IT) is a phase II study that seeks to determine whether patients who suffer an intracranial hemorrhage (ICH) and show contrast extravasation on CT angiography (CTA) can benefit from a coagulation factor treatment with recombinant Factor Vila (rFVIIa). In an unselected population of patients with ICH preliminary data showed that contrast extravasation during CTA (spot sign) predicts hematoma expansion and poorer neurological outcome. Patients with signs of ongoing ICH expansion may be more likely to benefit from rFVIIa treatment. In the STOP-IT study adult patients who present within 6 hours of an acute ICH will receive a head CT and CTA. Patients who show the spot sign, which is contrast extravasation into the hematoma seen on CTA will be randomized to receive 80ug/kg fFVIIa or placebo. We plan to contribute 30 patients in San Diego to a total of 364 patients study-wide over 5 years. The study will show if the spot sign can be identified reliably, if the spot sign correlates with outcome and if patients with a positive spot the spot sign benefit from treatment with rFVIIa. The primary outcome is measured as the percent of patients in each treatment group with hematoma that growth from baseline to the 24 hours CT scan.. This trial fits well with the other projects proposed by UCSD SPOTRIAS since there is no overlap with other trials, and the stroke team (see Core C) will be called in for intracerebral hemorrhages due to Code Stroke activation prior to a CT head scan.

预测和治疗脑出血生长研究的现场标志(STOP-IT)是一项II期研究，旨在 确定患有颅内出血(ICH)并表现为对比剂渗出的患者 CT血管造影(CTA)可受益于凝血因子与重组因子V1a(RFVIIa)的联合治疗。 在一组未选定的脑出血患者中，初步数据显示造影剂外溢在 CTA(斑点征)预测血肿扩大和较差的神经预后。有症状的患者 正在进行的脑出血扩大可能更有可能从rFVIIa治疗中受益。 在Stop-IT研究中，急性脑出血后6小时内出现的成年患者将接受头部CT和 CTA。CTA上显示斑点征的患者将出现血肿的对比剂渗出 随机接受80ug/kg的FFVIIa或安慰剂。我们计划在圣地亚哥贡献30名患者 在超过5年的研究范围内的364名患者中。这项研究将表明，如果现场标志可以可靠地识别，如果 斑点征与预后相关，如果患者的斑点呈阳性，斑点征将受益于 RFVIIa。主要结果以每一治疗组中出现血肿的患者的百分比来衡量。 从基线到24小时CT扫描的增长.. 此试验与UCSD SPOTRIAS提出的其他项目非常吻合，因为与其他项目没有重叠 试验，中风小组(见核心C)将因代码中风而被召唤来治疗脑出血 在CT头部扫描前激活。