BridgeMD
Compares treatment options for Stroke, Acute
Official title Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
ClinicalTrials.gov ID: NCT05649670
What this study is testing
- What it's testing
- ASPHALT is an academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. 450 patients with confirmed acute ischemic stroke will be recruited over a 3-year period, with 3-month follow-up.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Emergency call to one of the two following emergency medical service (EMS) dispatch centers : SAMU (Service d'Aide Médicale Urgente) or BSPP (Brigade...
- Suspected acute stroke according to a dispatcher stroke identification algorithm, adapted from the ROSIER scale
- Symptom onset-to-randomization time ≤ 6h
- Patient located within the predefined catchment area of the MSU
- MSU available at the time of the EMS call
You likely can't join if
- Patient confined to be more than 50% of waking hours
- Unknown or uncertain onset time (e.g. wake-up stroke)
- Medical history of epilepsy
- Recent epileptic seizure (\<12 hrs)
- Suspicion of pregnancy
- Parturient or breastfeeding woman
See the full eligibility criteria
- Emergency call to one of the two following emergency medical service (EMS) dispatch centers : SAMU (Service d'Aide Médicale Urgente) or BSPP (Brigade des Sapeurs Pompiers de Paris), between 08:00 and 18:00, 5 days a...
- Suspected acute stroke according to a dispatcher stroke identification algorithm, adapted from the ROSIER scale
- Symptom onset-to-randomization time ≤ 6h
- Patient located within the predefined catchment area of the MSU
- MSU available at the time of the EMS call
- Informed consent (as approved by the ethics committee, informed consent will be obtained after randomization: at the arrival of the MSU (intervention group), or at hospital arrival (control group))
- Patient confined to be more than 50% of waking hours
- Unknown or uncertain onset time (e.g. wake-up stroke)
- Medical history of epilepsy
- Recent epileptic seizure (\<12 hrs)
- Suspicion of pregnancy
- Parturient or breastfeeding woman
- Patient already participating in another treatment study, which could influence the mRS at 3 months.
- Patient under guardianship or curatorship
- Patient not affiliated to French Social Security
The study team makes the final eligibility decision.
Where it's taking place
- Garches, France
- Le Kremlin-Bicêtre, France
- Paris, France
- Suresnes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garches, France; Le Kremlin-Bicêtre, France; Paris, France; Suresnes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.