SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Difference of headache mean intensity variation measured after a lumbar puncture or a sham LP.
研究概览
简要总结
Headache control is one of the major challenges in patients who suffered an acute aneurysmal subarachnoid hemorrhage (aSAH). Headache affects 90% of the patient and is resistant to the major pain medication. It results from the increased intracranial pressure and the inflammation caused by the accumulation of arterial blood in the subarachnoid space. Hemorrhagic cerebrospinal fluid (CSF) removal by a lumbar puncture (LP), is well tolerated, reduces intracranial pressure and accelerates the clearance of the blood products from CSF. Nonetheless it has never been tested in a randomized trial. The investigators aim to compare in patients who experienced a low grade aSAH, the variation of headache intensity after CSF removal by LP vs. Sham LP in addition to predefined analgesic protocol management.
详细描述
After aneurysmal subarachnoid hemorrhage (aSAH) almost 90 % of patients experience a severe headache during their hospital stay. Pain control often requires high doses of opioid drugs and sedation that remain only partially efficacious. In addition, there is to the investigator's knowledge currently no recommendation or consensus on aSAH related headache management. aSAH related headache results from the prolonged increased intracranial pressure and meningeal inflammation related to the accumulation of blood products in the subarachnoid space. Preliminary studies, suggest that hemorrhagic cerebrospinal fluid (CSF) removal by lumbar puncture (LP) or lumbar drain, is safe and decreases intracranial pressure. However its impact on headache control has never been tested. A reliable headache evaluation has to be performed among conscious patients experiencing a "low-grade" aSAH.
The objective of the study is to evaluate in patients experiencing low-grade acute aSAH (WFNS 1-3), the efficacy of CSF removal by LP vs. sham LP, on headache control. 74 patients with secured aneurysm by coiling, will be randomized (1:1) between day 3 and day 5 after aneurysmal rupture. The procedure will be performed in addition to a pre-specified antalgic protocol.
Mean headache intensity will be measured with the numeric verbal scale during the 24 hours before and the 24 hours after the procedure. The variation of mean intensity will be compared between the 2 groups.
The investigators hypothesize that this treatment may significantly decrease headache intensity after an aSAH. If this hypothesis is confirmed CSF removal by LP could be a simple cost effective and worldwide available strategy to improve
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
This procedure is to be able to easily randomize half of the patients into a "sham" LP arm passed by independent practitioners of the investigators in charge of the patient, which allows a good double-blind study.
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
- •Age >18 years
- •Low grade subarachnoid hemorrhage (WFNS score between 1 and 3)
- •Aneurysmal rupture ≤ 5 days
- •Ruptured aneurysm secured by coiling since at least 48 h
- •Headache with a mean numeric verbal scale ≥ 4/10 during the last 24 hours
- •No contraindication for lumbar puncture
- •Affiliation to french social security
- •Person able to express her consent and to assess own headache intensity
排除标准
- •Pregnancy, breastfeeding
- •Subarachnoid hemorrhage without aneurysm
- •Ruptured aneurysm not secured
- •High grade (WFNS 4 and 5) subarachnoid hemorrhage
- •Efficient anticoagulation
- •External ventricular drain placed before randomisation
- •People under legal protection
- •Participation to another research study with an ongoing disqualification period
研究组 & 干预措施
Lumbar puncture
Lumbar puncture in addition to a predefined analgesic protocol Patients will be randomized between the 3rd and 5th days following aneurismal rupture.
干预措施: Lumbar puncture (Procedure)
Sham lumbar puncture
Sham lumbar puncture in addition to a predefined analgesic protocol Patients will be randomized between the 3rd and 5th days following aneurismal rupture.
干预措施: Lumbar puncture (Procedure)
结局指标
主要结局
Difference of headache mean intensity variation measured after a lumbar puncture or a sham LP.
时间窗: 24 hours after the inclusion
The mean intensity will be assessed using the verbal rating scales (VRS). It is a scale administered by the medical team, which brings together the score given by the patient between 0 and 10 (0 = absence of pain; 10 = maximum of conceivable pain)Headache mean intensity variation will be calculated by the difference between these scores evaluated 24 hours before and the 24 hours after the procedure.
次要结局
- Difference of responding patients(7 days)
- Persistence of Chronic hydrocephalus(3 month)
- Occurrence of a clinical deterioration(1 day)
- Difference of maximal headache intensity(48 hours)
- Kinetic of headache intensity(7 days)
- Improvement of the clinical global impression(3 months)
- Difference of variation in the mean intensity of headache(48 hours)