Individualized Blood Pressure Management During Endovascular Stroke Treatment

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION

• Registration Number: NCT04578288
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. Low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. Retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. Some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. Intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. We aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. For this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (PROBE).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-30
• Study Start: 2020-10-01
• Study First Posted: 2020-10-08
• Primary Completion: 2022-10-21
• Study Completion: 2022-10-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
2. Age 18 years or older, either sex
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 8
4. Acute ischemic stroke in the anterior circulation with isolated or combined occlusion of: Internal carotid artery (ICA) and/or middle cerebral artery (MCA)
5. Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment

Exclusion Criteria

1. Intracerebral hemorrhage
2. Coma on admission (Glasgow Coma Scale ≤ 8)
3. Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
4. Intubated state before randomization
5. Severe hemodynamic instability (e.g. due to decompensated heart insufficiency)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Blood Pressure management	INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION	The standard blood pressure management is maintenance of intraprocedural pre-recanalization SBP between 140-180 mmHg for all patients who receive endovascular thrombectomy for acute ischemic stroke in anterior circulation.
Individualized Blood Pressure management	INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION	The study intervention would be maintaining the intraprocedural pre-recanalization blood pressure in individualized SBP target ranges depending on the systolic blood pressure of the patient at presentation (=baseline SBP or bSBP).

Primary Outcome Measures

Name	Time	Method
Functional outcome 90 days after stroke onset	90 days	modified Rankin scale (mRS) after 90 days dichotomized 0-2 by (favorable outcome) to 3-6 (unfavorable outcome).

Secondary Outcome Measures

Name	Time	Method
Infarction size, determined with MRI or (in case of contraindications CT scan) 12-36 h after admission on a post-interventional follow up scan [milliliter]	12-36 hours	Infarction size 12-36 hours after symptom onset
Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission	24 hours	\[NIHSS on admission - NIHSS after 24 hours\]
Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion]	Duration of thrombectomy procedure up to 240 minutes	Duration of thrombectomy procedure
Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion]	Duration of thrombectomy procedure up to 240 minutes	Duration of thrombectomy procedure

Trial Locations

Locations (1)

Department of Neurology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany