Ultrasound for Acute Field Triage of Stroke (NCT05845203) | Clinical Trial Compass
CompletedNot Applicable
Ultrasound for Acute Field Triage of Stroke
France60 participantsStarted 2023-10-03
Plain-language summary
Acute ischemic stroke (AIS) is responsible for considerable morbidity and mortality worldwide and has serious medico-economic and psychosocial consequences. Before the advent of mechanical thrombectomy (TM), care and telestroke networks had focused their efforts on the rapid administration of a thrombolytic agent, tissue plasminogen activator (tPA), intravenously ( IV), to all eligible patients with ischemic stroke. These care networks have been shown to improve both patient prognosis by improving early vascular recanalization, the overall quality of neurovascular care within the network, and costs at network hospitals.
In 2015, the effectiveness of another treatment, TM, for some acute ischemic stroke patients with large vessel occlusion (LVO) created new challenges for the effective triage of suspected patients stroke, especially in the prehospital setting.Indeed, non-OLV patients should receive intravenous thrombolysis without delay and thus should be transported to the nearest facility with neurological capacity. thrombolysis.In contrast, the efficacy of thrombolysis remains limited for patients with LVO stroke who likely benefit from direct transport from the field to a comprehensive stroke center capable of performing TM. In these patients, stopping at a local center to initiate thrombolysis can delay revascularization and worsen the prognosis.These sorting strategy paradigms, called "mothership" and "drip and ship"
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Healthy subjects (recruitment via the CIC-IC):
* Adults (Age \>18),
* free from any known cerebral pathology,
* having given their informed, dated and signed free consent
* and affiliated with a French social security scheme (CMU accepted)
Stroke topics:
* Adult patients (age \>18 years),
* admission for suspected stroke with a severity scale assessed by an NIH Stroke Scale \> 10 with or without signs of cortical damage.
* Onset of symptoms \< 24 hours.
* Proximal arterial occlusion confirmed by angio-MRI or angio-scan,
* free informed consent, dated and signed,
* affiliated to a French social security scheme (CMU accepted).
Exclusion Criteria:
(healthy subjects and patients)
* Realization of the transcranial Doppler likely to delay the treatment of the patient
* Patient eligible for thrombectomy. vs
* Major agitation (+3 on the Richmond Agitation Sedation Scale) (done only when the patient is agitated).
* Inability of the patient to consent due to the severity of the clinical symptoms, and the absence of an available relative.
* History of severe head trauma, or significant deformation of the skull.
* Recent craniofacial trauma with recent scalp or facial wounds.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurements of cerebral pulsatility (maximum and average), peak diastolic and systolic velocity, peak systolic velocity, resistance index and pulsatility