RecruitingPhase 2ACTRN12620001128987

Effect of enoxaparin (a low molecular weight heparin) given in a single or split dose, on stroke occurrence after unruptured brain aneurysm treatment utilising coils or stents

Effect of single versus split dose enoxaparin post elective neurointervention on occurrence of thromboembolic events – a randomised study


Sponsor

Professor Alan Coulthard

Enrollment

124 participants

Start Date

Feb 10, 2021

Study Type

Interventional

Conditions

Summary

Thromboembolic events are frequent adverse events in neurointerventional procedures such as cerebral aneurysm coiling and stenting. Ischaemic lesions are visible on MRI diffusion weighted imaging (DWI). These can be further characterised as clinically evident or clinically silent. They are clinically evident ischaemic lesions(CEIL) if a neurological deficit is present, or clinically silent ischaemic lesions (CSIL) if not. Most ischaemic strokes occur 4-12 hours post procedure. The overall incidence of DWI lesions post endovascular cerebral aneurysm treatment has been reported as 49-60% and the literature suggests that they can increase the risk of dementia and cognitive decline. To assess the efficacy of enoxaparin (a low molecular weight heparin) in prevention of thromboembolic events, patients will be randomised to receive one of two enoxaparin dose regimens post elective endovascular aneurysm treatment: (A) subcutaneous enoxaparin 1mg/kg at T=0 and T=12hrs (split dose); or (B) subcutaneous enoxaparin 1.5mg/kg (single dose) at T=0. T=0 refers to the end of the endovascular procedure. Each patient will have pre and post-procedure MRIs. The primary outcome of interest is the proportion of patients who have thromboembolic events assessed by neurological examination at 24 hours and MRI at 48hrs. Secondary outcomes include the frequency of puncture site complications and haemorrhage assessed through clinical monitoring. We hope to learn which enoxaparin dose regimen should be recommended to neurointerventionists.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial examines the best way to give an anti-clotting medication called enoxaparin after a procedure to treat a brain aneurysm using a catheter (endovascular coiling or stenting). During these procedures, tiny clots can sometimes form in the blood vessels and travel to the brain, potentially causing a stroke — even when symptoms aren't immediately obvious. Preventing these clots is important, especially because even silent clots on MRI scans may increase the long-term risk of dementia. Participants will be randomly assigned to receive enoxaparin in one of two dose schedules: either a single dose or a split dose given over 12 hours. Both groups will have MRI scans before and after the procedure to check for any clot-related changes. The study will tell doctors which dosing approach is better at preventing clots while minimising bleeding risks. You may be eligible if you are 18 or older, have been admitted for planned (elective) endovascular treatment of a brain aneurysm, and your doctor determines you need post-procedure anti-clotting medication. People presenting with a ruptured aneurysm, significant kidney impairment, a pacemaker (which prevents MRI), or who are pregnant are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants who have elective endovascular treatment of unruptured intracranial aneurysms requiring anticoagulation post procedure will be randomised to receive subcutaneous injections of either 1)

Participants who have elective endovascular treatment of unruptured intracranial aneurysms requiring anticoagulation post procedure will be randomised to receive subcutaneous injections of either 1) enoxaparin 1mg/kg at T=0 and T=12hrs (split dose); or 2) enoxaparin 1.5mg/kg at T=0 (single dose) (T=0 refers to end of procedure) Enoxaparin administration will be confirmed by reviewing the medication chart, nursing and/or medical progress notes. The operating interventional neuroradiologist does not know the trial arm allocation till the procedure is concluded.


Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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