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NCT Number: NCT03754335

SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture

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.

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Headache Hemorrhage Intracranial Hemorrhages Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, 31059, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Puncture

Procedure

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.

Other names: Sham Lumbar Puncture

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difference of variation in the mean intensity of headache

    Time frame: 48 hours

    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.

  2. Difference of maximal headache intensity

    Time frame: 48 hours

    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.

  3. Kinetic of headache intensity

    Time frame: 7 days

    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).

  4. Difference of responding patients

    Time frame: 7 days

    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.

  5. Occurrence of a clinical deterioration

    Time frame: 1 day

    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.

  6. Persistence of Chronic hydrocephalus

    Time frame: 3 month

    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.

  7. Improvement of the clinical global impression

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: SAH-HELP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2018
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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