SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture

NCT03754335 | Completed

• 2 other identifiers: RC31/17/03552018-A00629-46
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Headache

Keywords

Aneurysmal subarachnoid hemorrhage; lumbar puncture; headache

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after the inclusion

Secondary Outcomes (7)

• Difference of variation in the mean intensity of headache

  48 hours

• Difference of maximal headache intensity

  48 hours

• Kinetic of headache intensity

  7 days

• Difference of responding patients

  7 days

• Occurrence of a clinical deterioration

  1 day

Study Arms (2)

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.

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.

Procedure: Lumbar puncture

Interventions

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.

Also known as: Sham Lumbar Puncture

Lumbar puncture; Sham lumbar puncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Headache

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lionel Calvière, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, prospective monocentric trial evaluating in parallel groups

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 27, 2018
• Study Start: November 28, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)