Comparison of two drug thinning agents (unfractionated heparin and low-molecular weight heparin) for prevention of stroke after brain aneurysm treatment utilizing coils or stents

Phase 1

Completed

• Conditions: Intracranial Aneurysm; Intracranial Lesions; Stroke - Ischaemic; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12616001277437
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-12
• Study Completion: 2020-07-02
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 154

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be achievement of therapeutic range as assessed by APTT (UFH) or anti Xa (LMWH) testing<br><br>Patients will be categorized in a binary fashion – either being within the therapeutic range or being sub/supratherapeutic. [Within 24-48h hours of administered medication]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome 1: The frequency of thromboembolic complications (either symptomatic or asymptomatic) in post-operative intracranial aneurysm coiling, including stent or balloon assisted coiling within the first 24-48 hours after cessation of intraoperative heparin, as assessed by neurological examination and pre- / post- procedure MRI[Neurological Examination within 24 hours of conclusion of endovascular procedure<br>MRI brain scan within 48 hours after the conclusion of endovascular procedure];Secondary Outcome 2: The frequency of hemorrhagic complications in post-operative intracranial aneurysm coiling, including stent or balloon assisted coiling within the first 24-48 hours after cessation of intraoperative heparin, as assessed by neurological examination and pre- / post- procedure MRI[Neurological Examination within 24 hours of conclusion of endovascular procedure<br>MRI brain scan within 48 hours after the conclusion of endovascular procedure]