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

Efficacy of single versus split dose enoxaparin post elective neurointervention in prevention of thromboembolic events in adults- a randomised study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000478819

Acronym

EPPICS II

Enrollment

Registered

2021-04-21

Start date

2021-02-03

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Small silent strokes are a known complication after endovascular procedures done to treat brain aneurysms. This is due to small clots that could form around the coils or stents used to treat the aneurysm. Blood thinners are given after such procedures to prevent this. This trial attempts to assess the efficacy of the blood thinner enoxaparin, as to whether it is better to give patients 1mg/kg or 1.5mg/kg doses after endovascular procedures for brain aneurysms.

Interventions

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

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

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

Exclusion criteria

Patients 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

Outcome results