Early Predictors for Neurological Outcome After Traumatic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- ISNCSCI
研究概览
简要总结
This project investigates early predictors of neurological recovery after traumatic spinal cord injury through three main aims:
- MAP and vasopressors - determine whether continuous monitoring of mean arterial pressure (MAP) and the use of vasopressors in the ICU influence neurological outcome.
- Pharmacological interventions - evaluate the impact of other medications, particularly opioids in the acute stage, on recovery.
- Biomarkers - identify diagnostic and prognostic biomarkers (blood-borne or digital) from routine clinical measurements within the first year after injury.
Using high-frequency ICU data and advanced data science methods, the study seeks to provide insights that support individualized treatment strategies and improve outcomes after SCI.
详细描述
Study rationale In order to address the question whether MAP targets and pharmacological interventions affect the neurological outcome after traumatic SCI, a large sample size of longitudinal data is required. The BG Trauma Center Murnau is a level Ia trauma center in Bavaria (Germany) and approximately 120 patients are treated with acute traumatic SCI every year. Therefore the spinal cord injury center at the Trauma Center Murnau represents one of the largest centers in Europe specializing in the treatment of SCI.
A retrospective analysis of routinely collected data during the ICU stay would create an opportunity to investigate the relation of hemodynamic parameters, pharmacological interventions, and neurological recovery in a large cohort of individuals who sustained acute traumatic SCI.
A better understanding of the effect of interventions in the very acute stages of SCI on neurological recovery, as well as the identification of new biomarkers would be of utmost interest for physicians. The knowledge gain from this study could inform clinical decision-making in the future and would therefore ultimately improve the treatment of acute SCI.
Specific aims and hypothesis of the project:
AIM 1 Investigate if continuous monitoring of arterial pressure and augmentation via administration of vasopressors during the ICU stay affect the neurological outcome in individuals who sustained traumatic SCI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Data from patients who sustained traumatic SCI, and who
- •completed at least one neurological examination in the acute / sub-acute stage of injury (between the day of injury and 40 days post-SCI) and in the chronic stage of injury (the latest neurological assessment between day 70 and day 546 after SCI)
- •agreed to provide their medical data for research purposes in the European Multicenter Study about Spinal Cord Injury (EMSCI) database
- •specific for Cohort 1: MAP Cohort patients who
- •were initially admitted to the BG Trauma Center Murnau, or transferred for acute SCI care within two days after trauma
- •were treated in the intensive care unit (ICU) and underwent hemodynamic monitoring for at least 24 hours
- •specific for Cohort 2: Biomarker Cohort - patients who had at least five blood samples collected within the first year after injury, with the first sample obtained within two weeks post-injury
- •specific for Cohort 3: Opioid Cohort
- •- patients who were treated in the ICU and received opioid therapy, including detailed information on timing, dosage, and duration of administration
排除标准
- •Patients with non-traumatic spinal cord injury or non-spinal cord injury
- •Patients who were initially admitted and/or surgically treated in another hospital and transferred to the BG Trauma Center Murnau later than two days post-SCI
结局指标
主要结局
ISNCSCI
时间窗: Days after Injury (DAI) 1-546
International Standards for Neurological Classification about Spinal Cord Injury
次要结局
未报告次要终点
研究者
Iris Leister
Head of Research SCI
BG Unfallklinik Murnau