None listed
Conditions
Brief summary
Endovascular treatment of intracranial aneurysm with coils and stents requires procedural anticoagulation, most commonly with unfractionated intravenous heparin (UFH). Where the risk of thromboembolic complications is high (eg post stenting) heparinisation is continued for 24-48hrs post treatment. Post-procedural anticoagulation regimes aim for ‘therapeutic range’ based on repeated laboratory testing of sampled blood. In practice this can be difficult to achieve with consistency using UFH. Low molecular weight heparin (LMWH) offers some theoretical advantages over UFH but there is no published data on its use in neurointervention. We propose to compare post-procedural anticoagulation using UFH with LMWH (enoxaparin) in patients treated electively for intracranial aneurysms. Patients who meet entry criteria will be randomised to one of three regimes: a) UFH - continuous IV infusion, titrated by APTT test results (current standard of care) b) LMWH given as a single dose of 1.5mg/kg by subcutaneous injection at the end of the procedure c) LMWH given 1.0mg/kg by subcutaneous injection at the end of the procedure and at 12hours. The primary outcome will be achievement of therapeutic range as assessed by APTT (UFH) or anti Xa (LMWH) testing. The secondary outcome will be development of a clinically evident thromboembolic event (CETE) or a clinically silent lesion, either ischaemic (CSIL) or hemorrhagic (CSHL), assessed by neurological examination at 24 hours and MRI at 48hrs.
Interventions
Endovascular treatment of intracranial aneurysm with coils and stents requires procedural anticoagulation, most commonly with unfractionated intravenous heparin (UFH). Where the risk of thromboembolic complications is high (eg post stenting) heparinisation is continued for 24-48hrs post treatment. Post-procedural anticoagulation regimes aim for ‘therapeutic range’ based on repeated laboratory testing of sampled blood. In practice this can be difficult to achieve with consistency using UFH. Low m
Endovascular treatment of intracranial aneurysm with coils and stents requires procedural anticoagulation, most commonly with unfractionated intravenous heparin (UFH). Where the risk of thromboembolic complications is high (eg post stenting) heparinisation is continued for 24-48hrs post treatment. Post-procedural anticoagulation regimes aim for ‘therapeutic range’ based on repeated laboratory testing of sampled blood. In practice this can be difficult to achieve with consistency using UFH. Low molecular weight heparin (LMWH) offers some theoretical advantages over UFH but there is no published data on its use in neurointervention. We propose to compare post-procedural anticoagulation using UFH with LMWH (enoxaparin) in patients treated electively for intracranial aneurysms. Patients who meet entry criteria will be randomised to one of three regimes: a) UFH - continuous IV infusion, titrated by APTT test results (current standard of care) b) LMWH given as a single dose of 1.5mg/kg by subcutaneous injection at the end of the procedure c) LMWH given 1.0mg/kg by subcutaneous injection at the end of the procedure and at 12hours.
Sponsors
Royal Brisbane and Women's Hospital
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 3 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
< 18 years of age (i.e. paediatric population) - acute endovascular treatment (eg acute subarachnoid haemorrhage) - impaired renal function (eGFR < 30) - MRI contraindications (e.g. pacemakers)
Outcome results
None listed