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Spinal Cord Injury Registry - North American Clinical Trials Network

— Наблюдательное Spinal Cord Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No Treatment Given.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Канада
Следующий шаг
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Официальное название

Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury

Обзор

The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care.

Подробное описание

The participating centers include:

University of Texas Health Science Center, Houston; University of Toronto, Toronto; University of Virginia, Charlottesville; University of Louisville, Louisville; University of Maryland, Baltimore; Walter Reed National Military Medical Center, Bethesda; Thomas Jefferson University, Philadelphia; University of Miami, Miami; Brooke Army Medical Center, Fort Sam Houston; Louisiana State University Health Sciences Center, New Orleans; Vanderbilt University Medical Center, Nashville; Medical College Wisconsin, Milwaukee; Duke University, Durham

The NACTN Clinical Coordinating Center is located at:

Houston Methodist Hospital, Houston

The Center for Biostatistics is located at:

Houston Methodist Hospital, Houston

The Data Management Center is located at:

University of Louisville, Louisville

Preliminary work has been completed on the selection of data elements, data collection protocols, case record form design, and the design of a computer system for clinical data management and data quality control.

In the first phase of the network, data will be collected on the natural history of SCI. Although there is considerable data in the literature about the natural history of SCI, current changes in treatment appear to be modifying the natural history. In particular very early surgery, including decompression of the spinal cord and vertebral stabilization with instrumentation appears, in some cases of SCI, to be improving outcomes.

No treatment is given other than standard of care for SCI. Data is collected in hopes to help SCI patients in the future.

Вмешательства

  • Другое No Treatment Given
    Intervention is not given.

Первичные конечные точки

  • International Standards For Neurological Classification of Spinal Injury (ISNCSCI) [Срок оценки: Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months]

Критерии участия

Критерии включения

  • Any patient male or female > or equal to 18 years of age with first time spinal cord injury caused by trauma and has neurological deficit with paralysis (weakness) or loss of sensation (touch).
  • Has not received prior medical of surgical care for this injury at an intermediate hospital.
  • Must give informed consent

Критерии исключения

  • Any patient or family refusing consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 13 центров
  • University of Miami — Miami
  • University of Louisville Health Sciences Center — Louisville
  • Louisiana State University Medical Sciences Center in New Orleans — New Orleans
  • University of Maryland Medical Center — Baltimore
  • Walter Reed National Military Medical Center — Bethesda
  • Duke University — Durham
  • Thomas Jefferson University — Philadelphia
  • Hamid Shah, MD — Nashville
  • … и ещё 5 центров
Канада · 1 центр
  • University of Toronto/Toronto Western Hospital — Toronto

Публикации

  • Bak AB, Moghaddamjou A, Harrop JS, Aarabi B, Fehlings MG. The Impact of Interhospital Transfer on the Extent of Neurological Recovery in Acute Traumatic Spinal Cord Injury: Analysis of a Prospective Multicenter Data Set in 970 Cases. Neurosurgery. 2024 Jan 1;94(1):90-98. doi: 10.1227/neu.0000000000002642. Epub 2023 Aug 21. PMID 37607093

Идентификаторы

NCT: NCT00178724 · Pro00002187 · W81XWH-16-C-0031 · CTN16-2020(RG)

Первоисточники (государственные реестры)

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