Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Other: Adjusted medication
- Registration Number
- NCT04892511
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
Mechanical thrombectomy is a very effective treatment in patients who have suffered an acute ischemic stroke associated with intracranial large vessel occlusion. However, less than half of the patients achieve functional independence despite treatment. The optimization of blood pressure after mechanical thrombectomy based on the degree of recanalization achieved at the end of the procedure could improve the perfusion of the ischemic brain tissue thanks to the improvement of blood circulation provided by collateral circulation. For this, authorized hypotensive or hypertensive drugs will be used. Moreover, this individualized treatment would allow to decrease reperfusion injury and therefore decrease the risk of intracerebral bleeding complications and cerebral edema. Therefore, we designed a clinical trial in which the standard management of blood pressure after mechanical thrombectomy will be compared with a specific protocol in which blood pressure targets are applied according to the degree of recanalization obtained during the thrombectomy procedure. The beneficial effect and risk reduction of this treatment will translate into a better short and long-term outcome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 814
- Patients with acute ischemic stroke and large intracranial vessel occlusion within 24 hours after the onset of symptoms in whom mechanical thrombectomy has been performed.
- Successful recanalization, defined as a TICI score of 2b, 2c, or 3.
- Previous score on the modified Rankin scale (mRS) of 0, 1, or 2.
- The patient or her legal representative gives informed written or verbal consent
- ASPECTS score <6
- Vertebral, basilar, A2, P2 and M3-4 occlusion
- History of intracerebral hemorrhage
- Pregnant or breastfeeding patient
- Patient with congestive heart failure or recent/unstable coronary artery disease (<3 months)
- Dissection of aorta, cervical or cerebral or unruptured aortic / cerebral aneurysm or known arteriovenous malformation
- Any bleeding visible on baseline CT
- History of ventricular arrhythmias
- Use of MAO inhibitors
- Inclusion in other clinical trials.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimized hemodynamic treatment Adjusted medication Post-thrombectomy patients will have their blood pressure measured every 30 minutes for the first 24 hours after thrombectomy, and every 1 hour from 24 to 72 hours. Blood pressure objectives will depend on the degree of recanalization achieved after thrombectomy (see intervention section). The hypotensive or hypertensive treatments used will be noted.
- Primary Outcome Measures
Name Time Method Modified Rankin scale value 3 months State of functional independence, measured with the modified Rankin scale at 3 months (+/- 14 days).
- Secondary Outcome Measures
Name Time Method Mortality 3 months Mortality from any cause at 3 months post-thrombectomy
Intracranial hemorrhagic complication 72 hours Rate of any intracranial hemorrhagic complication in the first 72 hours after the procedure.
Infarct size in the 24-hour post-thrombectomy CT. 24 hours Infarct size in the 24-hour post-thrombectomy CT.
Infarct size in the 72-hour post-thrombectomy CT. 72 hours Infarct size in the 72-hour post-thrombectomy CT.
Cerebral edema 72 hours Volume of cerebral edema at 72 hours in the post-thrombectomy CT scan.
NIHSS score 24 hours
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain