SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
关键词
抽象
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
日期
| 最后验证: | 07/31/2019 |
| 首次提交: | 11/18/2018 |
| 提交的预估入学人数: | 11/22/2018 |
| 首次发布: | 11/26/2018 |
| 上次提交的更新: | 08/18/2019 |
| 最近更新发布: | 08/20/2019 |
| 实际学习开始日期: | 11/27/2018 |
| 预计主要完成日期: | 05/31/2020 |
| 预计完成日期: | 05/31/2020 |
状况或疾病
干预/治疗
Procedure: Lumbar puncture
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Lumbar puncture Lumbar puncture in addition to a predefined analgesic protocol Patients will be randomized between the 3rd and 5th days following aneurismal rupture. | |
| Active Comparator: 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - Minor, - 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 |
结果
主要结果指标
1. Difference of headache mean intensity variation measured after a lumbar puncture or a sham LP. [24 hours after the inclusion]
次要成果指标
1. Difference of variation in the mean intensity of headache [48 hours]
2. Difference of maximal headache intensity [48 hours]
3. Kinetic of headache intensity [7 days]
4. Difference of responding patients [7 days]
5. Occurrence of a clinical deterioration [1 day]
6. Persistence of Chronic hydrocephalus [3 month]
7. Improvement of the clinical global impression [3 months]
