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临床试验/NCT04189471
NCT04189471招募中不适用

Recovery After Cerebral Hemorrhage--Improving Outcomes for Patients With Life-Threatening Neurologic Illness

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2014年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Number of participants who score great than 26 on the Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

Background:

While the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support.

This can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies.

Purpose:

Examine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well.

This effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU.

In addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty.

详细描述

The objective of the proposed minimal-risk, non-interventional retrospective (January 2012 onwards) as well as prospective, cross-sectional observational study (i.e., NCCU Research Repository) is to better understand the common pathophysiological pathways of life-threatening neurological illnesses, examine how systemic complications (e.g., fever, hyperglycemia, undernutrition, and infections) and our standard-of care management of them may exacerbate brain injury, and determine the impact of injury and intervention on functionally-relevant outcomes.

A systematically collected cohort may have an especially important role in the NCCU where RCTs are difficult to implement or may lack generalizability, and wherein there are pitfalls in research derived solely from administrative databases. This relational database will capture all patients admitted to University of Maryland's dedicated 22-bed adult NCCU. The investigators will not initially collect all potentially relevant fields unique to specific diagnoses. However, future disease-specific studies will allow the addition of data fields in this flexible database environment. This approach will include the tiered acquisition of patient characteristics (age, sex), clinical characteristics, standard-of-care medical treatments and surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry etc), laboratory data, and diagnostic studies--particularly neurophysiology, neuropathology, and neuroimaging. Some data elements are inherently less reliable when abstracted from the electronic medical record (e.g., a more detailed social history, establishing premorbid functional status, and independent confirmation of past medical history), and will require an informed consent process to allow the research team to approach subjects or their surrogates.

Similar databases exist at other centers for neurocritical care and have been central to the identification of characteristics, both predictive and associative, of patient outcomes. Done properly, this repository can facilitate many NCCU priorities including hypothesis generating, determining feasibility of single-site trials or involvement in multi-center trials, multimodal monitoring, biomarker research, quality improvement, and resident education.

All data will be collected from the patient medical record, patient bedside monitors, radiology PACS, and laboratory systems. The collection of data will not affect nor delay patient treatment at any instance.

Potential subjects will include patients admitted to University of Maryland's 22-bed NCCU for treatment of a life-threatening neurological illness. All patients 18 years of age and older will be eligible for participation in the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of potentially life-threatening neurological illness
  • admitted to Neuro ICU within 14 days of initial injury

排除标准

  • known pre-existing neurological deficits related to a developmental disorder
  • prior severe stroke
  • prior severe dementia
  • prior severe head injury
  • prisoners

结局指标

主要结局

Number of participants who score great than 26 on the Montreal Cognitive Assessment (MoCA)

时间窗: 3 month

The Montreal Cognitive Assessment was developed as a quick screening tool for neurological function. It assesses the domains of attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculation, and orientation. The MoCA has been tested extensively for use in a variety of disorders affecting cognition such as HIV, Huntington's chorea, Multiple Sclerosis, Parkinson's disease, stroke, vascular dementia, and substance abuse in addition to the wellness of older adults. The MoCA has been tested in ages ranging from as young as 49 in two reports to old-old (85+) with a variety of education levels. The total possible score is 30 points with a score of 26 or more considered normal.

Number of participants who score 1 or less on the Modified Rankin Scale

时间窗: 3 month

The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke. Scores range from 0 to 6. A lower score signifies better outcomes, more independent functionality.

Number of participants who score great than 75 on the EuroQOL

时间窗: 3 month

EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Number of participants who score great than 60 on the Barthel Index

时间窗: 3 month

The Barthel scale is an ordinal scale used to measure performance in activities of daily living. Scores range from 0 to 100. A higher score signifies better outcomes, more independent functionality.

Number of participants who have experienced adverse events

时间窗: 3 month

Medical history from hospital discharge to three months will help researchers learn of any adverse events or other medical complications.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gunjan Parikh

Associate Professor

University of Maryland, Baltimore

研究点 (1)

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