RecruitingACTRN12623000970640

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.

Sponsor

University of Newcastle

Enrollment

50 participants

Start Date

Oct 24, 2024

Study Type

Interventional

Conditions

Elevated intracranial pressure

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After a stroke caused by a blocked artery, the brain tries to protect itself by rerouting blood flow through smaller "bypass" vessels. When pressure inside the skull rises, these bypass vessels can fail, allowing the stroke to worsen and cause more brain damage. This trial is investigating whether relieving that pressure could protect these vessels and limit stroke severity. The approach being tested is a lumbar puncture — commonly known as a spinal tap — a well-established procedure where a small amount of fluid is drawn from around the spinal cord. Researchers believe this can safely reduce the pressure in the skull after a stroke. This trial is the first step: checking whether a lumbar puncture can be performed safely in people who have just had a stroke. You may be eligible if you are 18 or older, had an ischaemic (clot-caused) stroke within the last 24 hours, and were reasonably independent before your stroke. People on blood thinners, anticoagulants, or those with bleeding disorders are not eligible. This study is sponsored by the University of Newcastle.

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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 procedu

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)

John Hunter Hospital - New Lambton

NSW, Australia

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ACTRN12623000970640