Acute Ischemic Stroke
Conditions
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
Interventions
OTHERAdjusted medication
In patients randomized to perfusion optimization, medication will be adjusted to maintain blood pressure according to the degree of recanalization: * Patients with TICI 2b: systolic blood pressure 140-160 mmHg. * Patients with TICI 2c-3: systolic blood pressure \<140 mmHg. Hypotensive drugs will be used when necessary. Intravenous labetalol is the treatment of choice, administered as a bolus or intravenous infusion. Alternative: urapidil (bolus or continuous infusion pump). If both drugs cannot be used or are insufficient, sodium nitroprusside can be used. Hypertensive drugs for TICI2b patients whose target pressure is 140-160mmHg and are below this range. Initially, a bolus of physiological saline or 100cc Plasmalyte® will be administered. If this treatment is not effective enough (blood pressure measurements persist \<140 mmHg), intravenous phenylephrine will be administered.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale value | 3 months | State of functional independence, measured with the modified Rankin scale at 3 months (+/- 14 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 3 months | Mortality from any cause at 3 months post-thrombectomy |
| Intracranial hemorrhagic complication | 24 hours | Rate of any intracranial hemorrhagic complication in the first 24 hours after the procedure. |
| NIHSS score | 24 hours | — |
| 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 | 24 hours | Volume of cerebral edema at 24 hours in the post-thrombectomy CT scan. |
Countries
Spain
Contacts
Primary ContactJoan Martí-Fàbregas, PhD, MD
Backup ContactPol Camps-Renom, PhD, MD
Outcome results
None listed