Clinical trial NCT03754335: SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
Official title: SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Headache
Keywords: Aneurysmal subarachnoid hemorrhage
lumbar puncture
headache
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, prospective monocentric trial evaluating in parallel groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Difference of headache mean intensity variation measured after a lumbar puncture or a sham LP.
timeFrame: 24 hours after the inclusion
Secondary outcomes:
measure: Difference of variation in the mean intensity of headache
timeFrame: 48 hours
measure: Difference of maximal headache intensity
timeFrame: 48 hours
measure: Kinetic of headache intensity
timeFrame: 7 days
measure: Difference of responding patients
timeFrame: 7 days
measure: Occurrence of a clinical deterioration
timeFrame: 1 day
measure: Persistence of Chronic hydrocephalus
timeFrame: 3 month
measure: Improvement of the clinical global impression
timeFrame: 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Lionel Calvière, MD
role: PRINCIPAL_INVESTIGATOR
References: