The efficacy of lumbar puncture in reducing intracranial pressure after stroke

Not Applicable

• Conditions: Ischaemic stroke; Elevated intracranial pressure; Stroke - Ischaemic

• Registration Number: ACTRN12623000970640
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-06
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients with acute ischaemic stroke confirmed on clinical and imaging criteria with onset (or time last known to be well) within 24 hours.
2. Patient’s age is greater than or equal to 18 years of age.
3. Premorbid mRS is less than or equal to 3.

Exclusion Criteria

1. 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.
2. Known bleeding diathesis and/or platelet count <100,000.
3. Patients who have received a thrombolytic agent in the previous 72 hours or are planned to receive a thrombolytic agent.
4. 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.
5. Basilar artery occlusion or posterior circulation stroke.
6. Pre-stroke mRS of >2 (indicating significant previous disability).
7. Any terminal illness such that patient would not be expected to survive more than 1 year.
8. 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.
9. Local skin infection at lumbar puncture site, or known spinal defect likely to impede lumbar puncture, e.g., significant scoliosis.
10. Patients with cognitive impairment as per treating neurologist.
11. Clinically evident pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of lumbar puncture complications (i.e., bleeding, low-pressure headache). A study-specific questionnaire will be used to determine whether the lumabr puncture prodecure was acceptable in terms of discomfort to the patient. Acceptability score of equal to or less than 30 out of a possible total of 40 points (75%) is required to deem the procedure ‘feasible’. [ Up to 3 months after stroke.]