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Hemostasis, Hematoma Expansion, and Outcomes After Intracerebral Hemorrhage

脑出血后的止血、血肿扩张和结果

基本信息

批准号：
9902563
负责人：
ANDREW M NAIDECH
金额：
$ 61.33万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9902563
关键词：
Acute Affect Age American Aminocaproic Acids Antifibrinolytic Agents Aspirin Blood Coagulation Factor VII Blood Platelets Brain Injuries Cerebral hemisphere hemorrhage Cessation of life Chicago Clinical Trials Coagulation Process Data Dependence Desmopressin Development Diagnostic Doctor of Philosophy Enrollment Factor VIIa Fibrinolysis Future Growth Hematoma Hemorrhage Hemostatic Agents Hemostatic function Hypomagnesemia Image Information Systems Intervention Intuition Lead Machine Learning Measurement Measures Medicine Myocardial Ischemia Nervous System Trauma Outcome Outcome Measure Pathway interactions Patient Outcomes Assessments Patient-Focused Outcomes Patients Pharmaceutical Preparations Platelet Transfusion Population Quality of life Recording of previous events Reporting Risk Scanning Stroke Survivors System Texas Thrombelastography Tranexamic Acid United States Food and Drug Administration United States National Institutes of Health Universities Vascular Diseases X-Ray Computed Tomography brain tissue clopidogrel disability effective therapy follow-up health related quality of life improved improved outcome machine learning algorithm metropolitan point of care prevent prospective stroke trials treatment strategy

项目摘要

PROJECT SUMMARY Intracerebral hemorrhage (ICH) is the most morbid form of stroke and has no treatment approved by the US Food and Drug Administration. Hematoma expansion (HE), interval growth of the hematoma, is a proximate cause of worse patient outcomes and death as larger hematomas displace brain tissue; hematomas > 60 mL reliably lead to disability or death at follow-up. Preventing HE is a promising strategy to improve outcomes for patients with ICH. Our relative inability to predict HE, however, has impeded the development of effective treatment strategies for ICH, and several clinical trials have been unsuccessful. Even when HE has been reduced, our ability to detect a benefit is hampered by relatively insensitive patient outcomes. This proposal will resolve two roadblocks that prevent the development of effective treatments for ICH, the most morbid form of stroke. Three comprehensive stroke centers (two from the Northwestern Medicine system in metropolitan Chicago, IL, and the University of Texas at Houston) will partner to prospectively enroll patients with ICH, measure hemostasis, measure HE, and record patient outcomes with state of the art assessments, including the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and NIH Toolbox. First, we will determine the mechanisms that lead to HE in acute ICH, broadly grouped into platelet activity, activation of coagulation, and fibrinolysis. Each can be specifically measured and has specific treatments to improve it. For example, reduced platelet activity due to aspirin can be reliably improved with desmopressin, delayed activation of coagulation may be related to hypomagnesemia, and accelerated fibrinolysis may be reduced with tranexamic acid or aminocaproic acid. Each will be examined for predicting HE; if multiple pathways are found, we will determine which are most important with machine learning. Once the most important mechanisms of hemostasis for HE are determined, we will explore if specific therapies improve platelet activity. It is possible that specific treatments for specific deficits in hemostasis will be more likely to reduce HE than single therapies applied to ICH patients generally (e.g., Factor VII). Once hemostatic mechanisms of HE are determine, we will determine the effect of HE on patient outcomes such as the modified Rankin Scale (mRS, a global ordinal scale), PROMIS, and NIH Toolbox. This will be crucial to plan for future clinical trials intended to improve patient outcomes through correcting abnormal hemostasis in acute ICH. Results will apply broadly to other bleeding conditions (e.g., neurotrauma).

项目总结