Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke (HOPE)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Enrolling; Phase 4

Conditions: Acute Ischemic Stroke

Treatments: Other: Adjusted medication

Study type: Interventional

Funder types: Other

Identifiers

NCT04892511

IIBSP-HOP-2021-01

Details and patient eligibility

About

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

Enrollment: 814 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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814 participants in 2 patient groups

Standard treatment

No Intervention group

Description:

Post-thrombectomy patients will have their blood pressure measured every hour for the first 24 hours after thrombectomy, and every 6 hours from 24 to 72 hours. The target blood pressure is not predefined by the study, but in patients who have received previous treatment with rt-PA, it is advisable to keep it below 180/110 mmHg. If the patient has not received rt-PA, there is no limitation, although the guidelines recommend keeping the pressure below 200/120 mmHg. The hypotensive or hypertensive treatments used will be noted.

Optimized hemodynamic treatment

Experimental group

Description:

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.

Treatment:

Other: Adjusted medication