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

Acute Ischemic Stroke Clinical Trial

— HOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892511
• Other study ID #: IIBSP-HOP-2021-01
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Joan Martí-Fàbregas, PhD, MD
• Phone: 0034 93 5537636
• Email: jmarti[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 814
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin scale value	State of functional independence, measured with the modified Rankin scale at 3 months (+/- 14 days).	3 months
Secondary	NIHSS score		24 hours
Secondary	Mortality	Mortality from any cause at 3 months post-thrombectomy	3 months
Secondary	Intracranial hemorrhagic complication	Rate of any intracranial hemorrhagic complication in the first 24 hours after the procedure.	24 hours
Secondary	Intracranial hemorrhagic complication	Rate of any intracranial hemorrhagic complication in the first 72 hours after the procedure.	72 hours
Secondary	Cerebral edema	Volume of cerebral edema at 24 hours in the post-thrombectomy CT scan.	24 hours
Secondary	Cerebral edema	Volume of cerebral edema at 72 hours in the post-thrombectomy CT scan.	72 hours
Secondary	Infarct size in the 24-hour post-thrombectomy CT.	Infarct size in the 24-hour post-thrombectomy CT.	24 hours
Secondary	Infarct size in the 72-hour post-thrombectomy CT.	Infarct size in the 72-hour post-thrombectomy CT.	72 hours