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SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture (SAH-HELP)

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ClinicalTrials.gov Identifier: NCT03754335
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Headache Procedure: Lumbar puncture Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double blind, prospective monocentric trial evaluating in parallel groups
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Headache

Arm Intervention/treatment
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.
Procedure: 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.

Other Name: Sham Lumbar Puncture

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.
Procedure: 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.

Other Name: Sham Lumbar Puncture




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754335


Contacts
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Contact: Lionel Calvière, MD 05 61 77 55 94 ext 33 calviere.l@chu-toulouse.fr
Contact: Audrey Tomasik 05 61 77 85 97 ext 33 tomasik.a@chu-toulouse.fr

Locations
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France
University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Lionel Calvière, MD    05 61 77 55 94 ext 33    calviere.l@chu-toulouse.fr   
Contact: Audrey TOMASIK    05 61 77 85 97 ext 33    tomasik.a@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Lionel Calvière, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03754335     History of Changes
Other Study ID Numbers: RC31/17/0355
2018-A00629-46 ( Other Identifier: ID-RCB )
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Aneurysmal subarachnoid hemorrhage
lumbar puncture
headache
Additional relevant MeSH terms:
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Headache
Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs