NCT04352296Completed
Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke
Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 433 (actual)
- First submitted
- 10 Apr 2020
- Start date
- 8 Mar 2021
- Primary completion date
- 16 Jan 2024
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Diseases
- Stroke, High blood pressure
- NCT number
- NCT04352296
What you commit to
- Study type: Interventional
- Participants enrolled: 433
- From 8 Mar 2021 to the primary completion date, 16 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intubation or induction of general anaesthesia prior to randomization
Other illness
- Intra-hospital onset of acute ischemic stroke, or secondary to a medical, interventional or surgical procedure (interventional cardiology, cardiac or vascular surgery) or any post-surgery ischemic stroke.
Other
- Contre-indication to mechanical thrombectomy
- Acute ischemic strokes associated with a posterior circulation large vessel occlusion (basilar artery, vertebral artery, posterior cerebral artery)
- Pre-existing neurological disability limiting neurological assessment at 3 months: mRS \>2 at randomization.
- Contraindication to iodinated contrast agents
- Known pregnancy or breastfeeding woman
Who the study is looking for
- Age \>18 years old
- Acute ischemic stroke due to an anterior large vessel occlusion: occlusion of the M1 or M2 segments of the middle cerebral artery, anterior cerebral artery (A1 segment), intracranial internal carotid artery, or tandem occlusions.
- Indication for mechanical thrombectomy under general anesthesia or conscious sedation within the first 6 hours from symptoms onset or within the first 24 hours if DAWN or DEFUSE-3 criteria are met.
- Affiliation to social security assurance.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Fondation Adolphe de Rothschild Coordinator of this site? Confirm its status | Paris | France | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.