The efficacy of lumbar puncture in reducing intracranial pressure after stroke
A safety and feasibility study of the capacity of lumbar puncture to reduce elevated intracranial pressure in acute ischaemic stroke.
University of Newcastle
50 participants
Oct 24, 2024
Interventional
Conditions
Summary
When an ischaemic stroke occurs and a major artery is blocked with a clot, some blood flow is re-routed to the stroke site via ‘bypass’ blood vessels (called collateral vessels) in order to prevent more brain cells from dying. Failure of these bypass vessels mean a stroke can continue to expand and the damage to the brain gets worse. Increased pressure in the skull, which occurs after stroke, can cause failure of these bypass vessels and thus make a stroke worse. We hypothesise that by removing some cerebrospinal fluid (the fluid that surrounds your brain) we can prevent pressure elevation after a stroke and therefore make the stroke less severe. The first thing we have to do is check whether we can safely take some cerebrospinal fluid from stroke patients. That is what this trial is designed to look at, whether we can safely take some cerebrospinal fluid from stroke patients.
Eligibility
Inclusion Criteria3
- Patients with acute ischaemic stroke confirmed on clinical and imaging criteria with onset (or time last known to be well) within 24 hours.
- Patient’s age is greater than or equal to 18 years of age.
- Premorbid mRS is less than or equal to 3.
Exclusion Criteria11
- Patients on anticoagulants and/or taking any antithrombotic agents (e.g., aspirin, clopidogrel). Patients taking any anticoagulant in the last 48 hours or warfarin within the last 5 days at any dose.
- Known bleeding diathesis and/or platelet count <100,000.
- Patients who have received a thrombolytic agent in the previous 72 hours or are planned to receive a thrombolytic agent.
- Intracranial haemorrhage (ICH) or other non-stroke diagnosis to explain the symptoms (e.g., tumour), or any intracranial space-ocupying lesion that could pose a risk of brain herniation identified by baseline imaging.
- Basilar artery occlusion or posterior circulation stroke.
- Pre-stroke mRS of >2 (indicating significant previous disability).
- Any terminal illness such that patient would not be expected to survive more than 1 year.
- Any condition that, in the judgement of the investigator could impose hazards to the patients if study therapy is initiated or affect the participation of the patient in the study.
- Local skin infection at lumbar puncture site, or known spinal defect likely to impede lumbar puncture, e.g., significant scoliosis.
- Patients with cognitive impairment as per treating neurologist.
- Clinically evident pregnant women.
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Interventions
This trial aims to determine whether aspiration of cerebrospinal fluid via lumbar puncture is a safe and feasible treatment to maintain intracranial pressure at 4-8 cm H2O after stroke. All procedures will take place after standard acute stroke care has been administered and within 24 hours of the stroke occurrence. All procedures will be undertaken by a clinician. Patients will undergo non-invasive intracranial pressure (nICP) monitoring using transcranial Doppler ultrasound and non-invasive peripheral arterial waveform monitoring. Time of lumbar puncture will be recorded. Close neurological observation will be conducted primarily during the first 48 hours after treatment administration according to local clinical practice. Lumbar puncture will take 30-45 minutes to complete. Undertaking of lumbar puncture will be noted by clinician in the patient medical records. Lumbar puncture involves insertion of a needle into the spinal canal to collect cerebrospinal fluid (CSF). The procedure is performed under local anaesthesia with a hypodermic needle. The person is placed on their side and bends their neck, so the chin is close to the chest, hunches their back, and brings their knees toward their chest (similar to a foetal position). The lower back is prepared using aseptic technique and local anaesthetic applied. A spinal needle is inserted between the lumbar vertebrae L3/L4, L4/L5, or L5/S1 and pushed until there is a ‘give’ as it enters the lumbar cistern. The needle is pushed further until there is a second ‘give’ that indicates the needle is now past the dura mater. The stylet from the spinal needle is then withdrawn and CSF is collected. The procedure is ended by withdrawing the needle while placing pressure on the puncture site. Non-invasive monitoring of intracranial pressure (nICP) involves use of two routinely clinically used non-invasive, painless procedures; transcranial Doppler ultrasound and non-invasive peripheral arterial waveform monitoring. Blood flow and pressure in the peripheral circulation and the brain are measured and the difference between the two is used to estimate the ICP. Transcranial Doppler ultrasound involves participants being fitted with a semi-rigid headpiece that uses sound waves to examine blood flow in the brain. Peripheral arterial waveform monitoring is done via finger cuff plethysmography which uses light to measure blood flow.
Locations(1)
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ACTRN12623000970640