A Prospective, Single-Arm Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants with headaches as assessed by a questionnaire
研究概览
简要总结
The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or reduce incidence of PLPH
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants who can sign informed consent
- •Participants who have stated willingness to comply with all study procedures and availability for the duration of the study
- •Participants receiving a LP per standard of care (SOC) need for diagnostic or therapeutic purposes only
- •Participants with Karnofsky Performance Scale (KPS) ≥ 60
排除标准
- •Participants with a past medical history of chronic headaches (≥15 days per month) or acute headaches
- •Participants with recent neurosurgical device implants such as ventriculoperitoneal shunt
- •Participants with more than one dural puncture during the same LP procedure
- •Participants have chronic coagulopathy with elevated prothrombin time (PT), Partial thromboplastin time (PTT), and International Normalized ration (INR).
- •Participants who are on active anticoagulant or antiplatelet therapy unless stopped such therapy prior to LP per SOC guidance.
- •Participants with suspicions of raised intracranial pressure by either clinical assessment or imaging assessment or both
- •Participants with severe spinal column deformities, such as scoliosis. Disc diseases are not exclusion criteria
- •Participants with LP procedural complications that require a needle type or needle size change
结局指标
主要结局
Number of participants with headaches as assessed by a questionnaire
时间窗: 5 days after LP
Participants will answer "Yes" or "No" in response to 1-2 questions: 1) Do you have a headache? Or have you had a headache since the lumbar puncture? 2) If you answered "Yes" to the previous question, does the headache get better when you sit up?
次要结局
- Number of participants that use the epidural blood patch(5 days after the LP)
研究者
Jay-Jiguang Zhu
Professor
The University of Texas Health Science Center, Houston