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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
814
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.
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGModified Rankin scale value
State of functional independence, measured with the modified Rankin scale at 3 months (+/- 14 days).
Time frame: 3 months
NIHSS score
Time frame: 24 hours
Mortality
Mortality from any cause at 3 months post-thrombectomy
Time frame: 3 months
Intracranial hemorrhagic complication
Rate of any intracranial hemorrhagic complication in the first 24 hours after the procedure.
Time frame: 24 hours
Intracranial hemorrhagic complication
Rate of any intracranial hemorrhagic complication in the first 72 hours after the procedure.
Time frame: 72 hours
Cerebral edema
Volume of cerebral edema at 24 hours in the post-thrombectomy CT scan.
Time frame: 24 hours
Cerebral edema
Volume of cerebral edema at 72 hours in the post-thrombectomy CT scan.
Time frame: 72 hours
Infarct size in the 24-hour post-thrombectomy CT.
Infarct size in the 24-hour post-thrombectomy CT.
Time frame: 24 hours
Infarct size in the 72-hour post-thrombectomy CT.
Infarct size in the 72-hour post-thrombectomy CT.
Time frame: 72 hours
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