A study to find the effect of different enoxaparin doses used on stroke occurrence after brain aneurysm coiling or stenting

Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: Subcutaneous administration of enoxaparin post endovascular procedures for intracranial aneurysms Patients are randomised into two arms with doses of either 1mg/kg 12 hours apart, or 1.5mg/kg as a single dose Administered subcutaneously immediately after the procedure, and 12 hours later if applicable All doses will be recorded in patient's medication chart CONDITION: Intracranial aneurysm;Stroke; ; Intracranial aneurysm ; Stroke Stroke ‐ Haemorrhagic Stroke ‐ Ischaemic PRIMARY OUTCOME: The proportion of patients per group who develop thromboembolic events detected as lesions on DWI MRI within 48 hours post endovascular treatment of intracranial aneurysms [At conclusion of study] SECONDARY OUTCOME: Frequency of haemorrhage ‐ major and minor ; a. Major haemorrhage – A clinically overt haemorrhage resulting in a fall of more than 30 g/L in haemoglobin; or a retroperitoneal, intracranial or intraocular haemorrhage ; b. Episodes of bleeding that were clinically overt but do not meet these criteria are considered minor haemorrhages ; [At conclusion of study] Intraparenchymal haemorrhage. This is assessed with MRI scanning of the brain to look for susceptibility weighted lesions within 48 hours post procedure[At conclusion of study] The proportion of patients who experience a puncture site complication such as haematoma, vessel dissection or pseudoaneurysm formation. This is assessed clinically or radiologically with ultrasonography or computed tomography[At conclusion of study] INCLUSION CRITERIA: Patients deemed fit for an elective endovascular aneurysm treatment Patients who require post procedure anticoagulation after intracranial endovascular aneurysm treatment. The criteria for post procedural anticoagulation are any of the following: 1) Placement of an Endovascular Device 2) Presence of procedural platelet aggregation 3) Increased risk of thromboembolic events due to (3a) large area of coil exposure at aneurysm neck (3b) loop protrusion into parent artery Able to understand the project and provide voluntary consent and continued participation
Epistemonikos ID: 4122f513f438327e1d6aebb1486242757e2cd744
First added on: Aug 25, 2024