NCT07602556尚未招募不适用
Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension: A Multi-center, Prospective, Randomized Controlled Trial
Beijing Tiantan Hospital0 个研究点目标入组 218 人开始时间: 2026年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 218
研究概览
简要总结
Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to leaks of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a new and promising alternative for current standard whole blood patching. However, there is no study comparing the efficacy and safety of the two approaches. In this study, we aimed to provide data concerning the outcomes of PRP patching versus conventional whole blood patching for treatment of refractory SIH cases failing in conservative therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent to participate the research obtained from the patient
- •Satisfies the criteria for SIH according to the International Classification of Headache Disorders.
排除标准
- •There was concern for other causes of intracranial hypotension, such as postdural puncture, postsurgical and post-traumatic CSF leaks
- •Prior treatment with EBP at any time previously
- •Any contraindication to epidural puncture, such as space-occupying intracranial or intraspinal lesions, spinal defect, suspected infection over the puncture site, bleeding disorder and current anticoagulation therapy
- •History of drug and alcohol abuse, cognitive dysfunction, or mental illness
- •Unable to cooperate with postoperative evaluation, treatment, rehabilitation, and follow-up visits
研究者
Fang Luo
Professor
Beijing Tiantan Hospital
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