NCT04892511

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

A Randomized Trial on Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke (HOPE Study)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 814 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
OTHER	Adjusted 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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2021-05-19
• Last updated: 2023-03-16

Locations

1 site across 1 country: Spain