Aneurysmal Subarachnoid HemorrhageSAH-HELPNCT03754335
SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
A study testing Lumbar puncture in people with Aneurysmal Subarachnoid Hemorrhage and Headache, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Headache
- What is being tested?
- Lumbar puncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2018to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minor,
- Pregnancy, breastfeeding
- Subarachnoid hemorrhage without aneurysm
- Ruptured aneurysm not secured
- High grade (WFNS 4 and 5) subarachnoid hemorrhage
- Efficient anticoagulation
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- External ventricular drain placed before randomisation
- People under legal protection
- Participation to another research study with an ongoing disqualification period
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Aneurysmal Subarachnoid Hemorrhage, Headache
- Being tested
- Lumbar puncture
- Keywords
- Aneurysmal subarachnoid hemorrhage, lumbar puncture, headache
- Medical subject headings
- Subarachnoid Hemorrhage, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar punctureProcedure or surgery
Also called Sham Lumbar Puncture
Patient will be managed according to the current international recommendations in the Toulouse acute stroke center.
In the absence of clear recommendation in the literature headache will be treated according to our local predefined analgesic protocol: paracetamol 1g/6 h, and if the numerical scale ≥ 4 : continuous intravenous morphine starting at 1mg/h and increased per 0.5 mg/h every hour if numerical scale remains ≥ 4.
Lumbar puncture will be performed between day 3 and day 5 after subarachnoid hemorrhage onset by an independent scientist from our clinical investigator center. 30-mL CSF will be removed by LP.
Sham LP consisting in superficial skin puncture by a subcutaneous needle (27 gauge needle) during the usual procedure will be performed at the same time point.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar puncture | Experimental | Lumbar puncture in addition to a predefined analgesic protocol Patients will be randomized between the 3rd and 5th days following aneurismal rupture. Receives: Procedure: Lumbar puncture |
| Sham lumbar puncture | Active comparator | Sham lumbar puncture in addition to a predefined analgesic protocol Patients will be randomized between the 3rd and 5th days following aneurismal rupture. Receives: Procedure: Lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of headache mean intensity variation measured after a lumbar puncture or a sham LP.
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.
Measured: 24 hours after the inclusion
Secondary outcomes (7)
Difference of variation in the mean intensity of headache
Difference of variation in the mean intensity of headache measured by the nurse in charge of the patients every 4 h between the 24 hours before and the 24 hours after the procedure. Difference of variation 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.
Measured: 48 hours
Difference of maximal headache intensity
Difference of maximal headache 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 maximal intensity variation will be calculated by the difference of maximal headache intensity measured during 24 hours before and 24 hours after the procedure by the nurse in charge of the patients every 4 hours.
Measured: 48 hours
Kinetic of headache intensity
Kinetic of headache intensity during the 7 days following the procedure (global assesment by the patient and mean/max of measurement every 4 hours). The headache 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).
Measured: 7 days
Difference of responding patients
Difference of responding patients defined by patients with a decreased of the mean intensity of 30 % and 50 %, 24 hours after the procedure and daily during the 7 days following the procedure.
Measured: 7 days
Occurrence of a clinical deterioration
Related to the other complication of subarachnoid hemorrhage : Occurrence of a clinical deterioration related to delayed cerebral ischemia assessed by NIHSS and GCS) and the occurrence of a new infarction on follow-up MRI.
Measured: 1 day
Persistence of Chronic hydrocephalus
Rate of chronic hydrocephalus defined by the modification of the ventricle size between the post interventional MRI and the follow-up MRI at 3 months.
Measured: 3 month
Improvement of the clinical global impression
Disability and Quality of life : Improvement of the "Clinical Global Impression -Improvement" (CGI-I) at 24 hours, day 7 and 3 months (clinical improvement defined by a score of 1 or 2). The CGI-I is used by clinicians to rate improvement in a subject's condition (benefits) since baseline. It is a 7-point scale with 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; and 7=very much worse.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start28 Nov 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, prospective monocentric trial evaluating in parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel Calvière, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754335
- Sponsor's protocol ID
- RC31/17/0355
- Other IDs
- 2018-A00629-46
- Acronym
- SAH-HELP
- Status last verified
- May 2026
- First submitted
- 19 Nov 2018
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
- ClinicalTrials.gov ID
- NCT03754335
- Acronym / sponsor ID
- SAH-HELP / RC31/17/0355
- Conditions
- Aneurysmal Subarachnoid Hemorrhage, Headache
- Keywords
- Aneurysmal subarachnoid hemorrhage, lumbar puncture, headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, prospective monocentric trial evaluating in parallel groups
| Arm | Type | Receives |
|---|---|---|
| Lumbar puncture | Experimental | Procedure: Lumbar punctureLumbar puncture in addition to a predefined analgesic protocol Patients will be randomized between the 3rd and 5th days following aneurismal rupture. |
| Sham lumbar puncture | Active comparator | Procedure: Lumbar punctureSham lumbar puncture in addition to a predefined analgesic protocol Patients will be randomized between the 3rd and 5th days following aneurismal rupture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- Minor,
- Pregnancy, breastfeeding
- Subarachnoid hemorrhage without aneurysm
- Ruptured aneurysm not secured
- High grade (WFNS 4 and 5) subarachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar punctureAlso: Sham Lumbar PuncturePatient will be managed according to the current international recommendations in the Toulouse acute stroke center. In the absence of clear recommendation in the literature headache will be treated according to our local predefined analgesic protocol: paracetamol 1g/6 h, and if the numerical scale ≥ 4 : continuous intravenous morphine starting at 1mg/h and increased per 0.5 mg/h every hour if numerical scale remains ≥ 4. Lumbar puncture will be performed between day 3 and day 5 after subarachnoid hemorrhage onset by an independent scientist from our clinical investigator center. 30-mL CSF will be removed by LP. Sham LP consisting in superficial skin puncture by a subcutaneous needle (27 gauge needle) during the usual procedure will be performed at the same time point. | Procedure or surgery | Lumbar puncture, Sham lumbar puncture |
Primary outcome
Difference of headache mean intensity variation measured after a lumbar puncture or a sham LP.
Time frame: 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.
7 secondary outcomes
Difference of variation in the mean intensity of headache
Time frame: 48 hours
Difference of maximal headache intensity
Time frame: 48 hours
Kinetic of headache intensity
Time frame: 7 days
Difference of responding patients
Time frame: 7 days
Occurrence of a clinical deterioration
Time frame: 1 day
Persistence of Chronic hydrocephalus
Time frame: 3 month
Improvement of the clinical global impression
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel Calvière, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar puncture in people with Aneurysmal Subarachnoid Hemorrhage and Headache, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of headache mean intensity variation measured after a lumbar puncture or a sham LP. (time frame: 24 hours after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.