A pilot trial of the MAnagement of Systolic blood pressure during Thombectomy byEndovascular Route for acute ischaemic STROKE (MASTERSTROKE)
- Conditions
- StrokeThrombectomyStroke - Ischaemic
- Registration Number
- ACTRN12618001035213
- Lead Sponsor
- Dr Douglas Campbell
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 51
Functionally independent patients (mRS 0 – 2) diagnosed with anterior circulation stroke (internal carotid artery or proximal M1 or M2 segment of middle cerebral artery)
presenting within six hours of stroke onset who fulfil current guidelines for thrombectomy.
Rescue’ procedures eg acute ischaemic stroke associated with major medical procedures such as coronary artery stenting and coronary artery bypass.
• Prestroke
mRS score of 3 (indicating previous disability)
• Contraindication to imaging with contrast agents
• Any terminal illness with expected survival less than 1 year
• Pregnant women
• Any medical condition where there is a contraindication to either treatment arm, or haemodynamic targeting will be problematic eg. severe aortic regurgitation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Recovery as determined by a modified Rankin Score scores of 0, 1 or 2 at 3 months.[Day 90 Post thrombectomy]
- Secondary Outcome Measures
Name Time Method eurological improvement defined by National Institute of Health Stroke Scale (NIHSS)[24 hours post thrombectomy];all-cause mortality confirmed by patient follow-up and clinical note review. [90 days post thrombectomy];Proportion of patients with intra-procedural complications (vessel perforation, dissection, devicerelated<br>complications, haemodynamic and airway complications, reperfusion syndrome, thrombus<br>migration or restenosis, seizures during treatment, groin haematoma)[From randomization until day 90];Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment,<br>associated with an increase of NIHSS of at least 4 points from baseline), including :<br> subarachnoid haemorrhage associated with clinical symptoms <br> symptomatic intracerebral haemorrhage (parenchymal haematoma type 2).[From randomisation until 36 hours post treatment.]