Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
试验速览
- 阶段
- 2 期
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients
研究概览
简要总结
Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups:
- Minimizing the neurological damage among trauma patients.
- Preventing neurological damage through operation in spinal tumors patients.
2.OBJECTIVES
The primary objectives of the trial are to determine:
- Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients?
- Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
- Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- •Inclusion Criteria:
- •Patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- •Ages: 18 to 65
- •Males - including those involved in active military duty.
- •Females - of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. Pregnant women will be excluded from the study.
排除标准
- •Complete cord transection, severe head injury, coma, or other disease of the CNS, and spinal injury diagnosed later than 24 hours.
- •Pregnant women (minocycline can cause fetal harm) and children.
- •Lower extremity fractures, mildly reduced consciousness and frail cognitive status will not be considered for exclusion.
- •Patients who will not be enrolled will be listed and reason for non inclusion will be recorded.
- •Spinal tumors:
- •Inclusion Criteria:
- •Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.
- •Exclusion criteria:
- •1.Intramedullary tumors or tumors causing complete cord syndrome
研究组 & 干预措施
Placebo, Spinal cord tumors, quality of life
干预措施: placebo (Drug)
Minocycline, Spinal Tumor patients, quality of life
干预措施: Minocycline (Drug)
Minocycline, Trauma patuents, quality of life
干预措施: Minocycline (Drug)
Placebo, Trauma patients, quality of life
干预措施: placebo (Drug)
结局指标
主要结局
Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients
时间窗: six months
The Efficacy will be evaluated using the following measures: 1. ASIA SCORE - We will compare the results before administrating the study medication and after six months of follow up. The ASIA score will be the Primary Efficacy Endpoint. 2. The Spinal Cord Independence Measure and Functional Independence Measure outcome scales. 3. Objective reduction in lesion size by imaging modalities
次要结局
- Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.(six months)
- Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?(six months)
研究者
Benjamin Drenger
Associate Professor of Anesthesia, Director, Orthopedic Anesthesia,
Hadassah Medical Organization