Regional Strategy for Transfer for Mechanical Thrombectomy

• Conditions: Large Vessel Occlusion; Stroke; Ischemic

• Registration Number: NCT04046757
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the Comprehensive Stroke Center of Montpellier, those transferred after Proximity Stroke Unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the Comprehensive Stroke Center of Montpellier

Detailed Description

Multiple RCT has recently proved the superiority of mechanical thrombectomy compared to the best medical therapy (BMT) on patients with recent cerebral infarct and anterior circulation intracranial large vessel occlusion.

In the Occitanie-Est region (ex Languedoc Roussillon), comprising 6 Stroke Unit, only the Comprehensive Stroke Unit of the CHU de Montpellier has a centre of interventional neuroradiology (NRI) that can perform mechanical thrombectomy.

Patients suspected of stroke are referred to the nearest SU, then the candidates for thrombectomy, are transferred secondarily to the Stroke Center in Montpellier.

Currently, there is no evidence that an initial management in a proximity stroke unit and a secondary transfer for a mechanical thrombectomy is associated with a loss of chance for patients, compared to patients initially treated at the Stroke Center regional reference.

The objective of the study is to compare clinical outcome on patients admitted first in the Comprehensive Stroke Center of Montpellier those transferred after Proximity Stroke Unit or directly admitted when high suspicion of large vessel occlusion.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Study Start: 2019-10-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age
2. With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient ≤ 12 h)
3. With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner)
4. No objection of the patient or their representative to being included in the cohort

Exclusion Criteria

1. Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible
2. Predictable impossibility of patient follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score (mRS)	3 months	Good functional outcome ( defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset Modified Rankin scale . Range 0 (asymptomatic) to 6 (death); * Good outcome : 0 to 2; * Disability : 3 to 5; * Bad outcome : 5 and 6

Secondary Outcome Measures

Name	Time	Method
Clinical evolution 7 days	7 days	NIHSS scale and NIHSS scale variation between the inclusion at 7 days; National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase : * Minor stroke : 0 to 5; * Moderate stroke 6 to 20; * Severe stroke up to 21
Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.	24 hours	Number of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.
Symptomatic Intracerebral Haemorrhage	24 hours	symptomatic Intracerebral Haemorrhage on cerebral imaging at 24 hours
Arterial Recanalisation with TICI score	post-act / 24 hours	Quality of revascularization after mechanical thrombectomy : immediate post-Mechanical-Trombectomy evaluation for patient having had mechanical thrombectomy and at 24 hours for all patient cohort.; TICI score (Thrombolysis In Cerebral Infarction grading system) describe the quality of revascularization after mechanical thrombectomy (Grade 0 for no perfusion at 3 for Complete perfusion)
Incidence of mechanical thrombectomy treatment	24 hours	Safety of medical complication; Complications of mechanical thrombectomy : * Vessel perforation; * Intramural Arterial dissection; * Symptomatic Intracerebral hemorrhage; * embolization to a new territory
Clinical evolution at 24 hours	24 hours	NIHSS scale and NIHSS scale variation between the inclusion at 24 hours; National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase : * Minor stroke : 0 to 5; * Moderate stroke 6 to 20; * Severe stroke up to 21

Trial Locations

Locations (1)

Gui De Chauliac Hospital; 🇫🇷 Montpellier, France