Clinical trial NCT04046757: Regional Strategy for Transfer for Mechanical Thrombectomy
Official title: Strategy for Transfer to Emergency Head And Neck (UTEC) of Stroke Alerts With Suspicion of Large Vessel Occlusion for Mechanical Thrombectomy in the Languedoc Roussillon Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Ischemic
Large Vessel Occlusion
Keywords: Ischemic stroke
Mechanical Thrombectomy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute cerebral infarct in the arterial circulation with large vessel occlusion

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Score (mRS)
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of mechanical thrombectomy treatment
timeFrame: 24 hours
measure: Clinical evolution at 24 hours
timeFrame: 24 hours
measure: Clinical evolution 7 days
timeFrame: 7 days
measure: Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.
timeFrame: 24 hours
measure: Symptomatic Intracerebral Haemorrhage
timeFrame: 24 hours
measure: Arterial Recanalisation with TICI score
timeFrame: post-act / 24 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Gui De Chauliac Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Caroline ARQUIZAN, MD
role: PRINCIPAL_INVESTIGATOR
References: