None listed
Conditions
Brief 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.
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) 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
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.
Sponsors
Professor Alan Coulthard
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients admitted for elective endovascular treatment of intracranial aneurysm are eligible for inclusion. Participants should understand the project and provide voluntary consent Eligible patients will be admitted to the study if at the end of the endovascular procedure the operator determines that a period of post procedural anticoagulation is clinically indicated. The three most common reasons for this are: 1) Placement of an indwelling endovascular device, such as a stent 2) Presence of procedural platelet aggregation 3) Perceived increased risk of thromboembolic events due to (3a) large area of coil exposure at aneurysm neck (3b) loop protrusion into parent artery
Exclusion criteria
- Under 18 years of age (i.e. paediatric population) - Patients presenting with acute subarachnoid haemorrhage - Patients with significantly impaired renal function (eGFR < 30) - Patients not suitable for 3T MR imaging (e.g. pacemakers) - Pregnant women - Patients deemed not to require anti-coagulation post-procedure
Outcome results
None listed