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前瞻性试验:通过腰椎导管对蛛网膜下腔出血后的脑脊液进行过滤(PILLAR)。

Prospective Trial of Cerebrospinal Fluid Filtration After Aneurysmal Subarachnoid Hemorrhage via Lumbar Catheter (PILLAR).

机构信息

From the Vivian L. Smith Department of Neurosurgery, University of Texas Health Science Center, Houston (S.L.B.).

Department of Neurosurgery (A.W.G.), University of Minnesota, Minneapolis.

出版信息

Stroke. 2019 Sep;50(9):2558-2561. doi: 10.1161/STROKEAHA.119.025399. Epub 2019 Jul 26.

Abstract

Background and Purpose- The PILLAR (Extracorporeal Filtration of Subarachnoid Hemorrhage via Spinal Catheter) study is a first-in-human trial of cerebrospinal fluid (CSF) filtration in aneurysmal subarachnoid hemorrhage. The study evaluates the safety and feasibility of a novel filtration system to rapidly remove blood and blood breakdown products from CSF after securement of a ruptured aneurysm. Methods- Patients with aneurysmal subarachnoid hemorrhage had a dual-lumen lumbar, intrathecal catheter placed after aneurysm securement and received up to 24 hours of CSF filtration (neurapheresis therapy). The catheter aspirated blood-contaminated CSF from the lumbar cistern and returned filtered CSF to the thoracic subarachnoid space. Neuro checks were performed q2 hours, and CSF samples were collected for cell counts, total protein, and gram stain. Computed tomography scans were acquired at baseline and post-filtration. Clinical follow-up occurred at 2 weeks and 30 days. Results- Thirteen patients had a catheter placed (mean time 24:13 hours after ictus). The system processed 632.0 mL (180.6-1447.6 mL) CSF in 15:07 hours (5:32-24:00 hours) of filtration. The mean initial CSF red blood cell count, 2.78×10 cells/µL, reduced to 1.17×10 cells/µL after filtration (52.9% reduction), and total protein reduced 71%. Independent analysis of baseline and postfiltration computed tomographies found notable cisternal blood decrease, with 46.5% mean Hijdra Score reduction. Three mild, anticipated adverse events were reported. Conclusions- The initial safety and feasibility of Neurapheresis therapy in aneurysmal subarachnoid hemorrhage demonstrated the potential to safely filter CSF and remove blood and blood byproducts. Future studies are warranted. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT0287263.

摘要

背景与目的- PILLAR(蛛网膜下腔出血经椎管内导管体外过滤)研究是首例在人类中进行的蛛网膜下腔出血脑脊液(CSF)过滤的临床试验。该研究评估了一种新型过滤系统的安全性和可行性,该系统可在安全固定破裂的动脉瘤后,迅速从 CSF 中清除血液和血液分解产物。方法- 蛛网膜下腔出血的患者在动脉瘤固定后放置了双腔腰椎、鞘内导管,并接受了长达 24 小时的 CSF 过滤(神经吸引治疗)。导管从腰椎池抽吸受污染的 CSF,并将过滤后的 CSF 返回到胸蛛网膜下腔。每 2 小时进行神经检查,并收集 CSF 样本进行细胞计数、总蛋白和革兰氏染色。在基线和过滤后进行 CT 扫描。临床随访在 2 周和 30 天进行。结果- 13 名患者放置了导管(发病后 24:13 小时的平均时间)。该系统在 15:07 小时(5:32-24:00 小时)的过滤过程中处理了 632.0 mL(180.6-1447.6 mL)CSF。初始 CSF 红细胞计数的平均值为 2.78×10 个/µL,过滤后降至 1.17×10 个/µL(减少 52.9%),总蛋白减少 71%。对基线和过滤后 CT 扫描的独立分析发现,脑池内血液明显减少,Hijdra 评分平均降低 46.5%。报告了 3 例轻微、预期的不良事件。结论- 在蛛网膜下腔出血中进行神经吸引治疗的初步安全性和可行性表明,安全过滤 CSF 并清除血液和血液副产物具有潜力。需要进一步的研究。临床试验注册- URL:https://www.clinicaltrials.gov。唯一标识符:NCT0287263。

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