Two-site Blind Epidural Patch Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension: A Prospective, Assessor Blind, Randomized, Controlled, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 58
- 主要终点
- Pain NRS of orthostatic headache
研究概览
简要总结
Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to loss of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a successful alternative for whole blood in dura repair. However, there is no report regarding the best approach to use: targeted epidural PRP patch (TEPP) versus blind epidural PRP patch (BEPP). Preliminary work has suggested that both targeted and blind approaches are effective when using whole blood for epidural patch. Furthermore, two-site blind approach could be considered as a viable initial treatment regardless of the identification of the leak for conventional targeted approach. In this study, the investigators aimed to investigate the non-inferiority of two-site BEPP compared with TEPP for the 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
- 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
- •Informed consent to participate the research obtained from the patient.
- •Age 18-65 years.
- •Satisfies the criteria for SIH according to the International Classification of Headache Disorders criteria for headaches attributed to spontaneous (or idiopathic) low CSF pressure.
- •Failed conservative management (bed rest oral or intravenous hydration, and analgesics) lasting at least 2 weeks.
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 comprehend the pain NRS.
- •Unable to cooperate with postoperative treatment, rehabilitation, and follow-up visits.
研究组 & 干预措施
Blind epidural PRP patch (BEPP)
Two-site blind epidural patch with PRP, which was prepared with the 2-stage centrifugation method, at levels C7-T1 and L4-5.
干预措施: Blind epidural PRP patch (Procedure)
Targeted epidural PRP patch (TEPP)
Targeted epidural patch with autologous platelet-rich plasma, which was prepared with the 2-stage centrifugation method.
干预措施: Targeted epidural PRP patch (Procedure)
结局指标
主要结局
Pain NRS of orthostatic headache
时间窗: 48 hours following epidural patch with PRP
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for headache.
次要结局
- The good response rate of epidural patch with PRP(48 hours, 1, 3 and 6 months post-procedurally)
- Pain NRS of orthostatic headache(1, 3 and 6 months following epidural patch with PRP)
- The complete relief rate of epidural patch with PRP(48 hours, 1, 3 and 6 months after the initial targeted or blind patch)
- The recurrence rate in each group.(During the 6-month follow up)
- The failure rate of epidural patch with PRP(48 hours following the initial epidural patch with PRP)
- The occurrence of complications(During and after the epidural patch with PRP until the end of 6-month follow up)
- The percent of patients requiring repeat epidural PRP patch(During the 6- month follow up)
- Patients' overall satisfaction(6 months following the first epidural patch with PRP)
研究者
Fang Luo
Professor
Beijing Tiantan Hospital