IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke

University of Aarhus

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Standard blood pressure management; Procedure: Individualized blood pressure management

Study type: Interventional

Funder types: Other

Identifiers

NCT04749251

IDEAL BP Feasibility Study

Details and patient eligibility

About

The ideal blood pressure management strategy during endovascular therapy (EVT) for acute ischemic stroke has not been defined. The aim of this pilot randomized clinical trial is to determine whether randomization to a standard versus individual blood pressure management strategy during the EVT procedure is feasible.

Full description

Acute ischemic stroke (AIS) is a leading cause of death and long-term disability in the Western world. Catheter-based removal of blood clots (endovascular therapy-EVT) is now the standard of care for AIS caused by large vessel occlusions in the brain. The level of blood pressure during the procedure appears to influence outcome. However, optimal blood pressure management strategy has not been determined. Current blood pressure management strategy during EVT typically aims to maintain blood pressure above or within predefined fixed targets and is based on observational data and expert consensus rather than on high-quality randomized evidence. Should blood pressure during removal of the occlusion be managed according to the patient's individual blood pressure level or according to predefined fixed blood pressure targets? The primary aim of this pilot trial is to determine whether randomization to a procedure strategy targeting a predefined mean arterial blood pressure (MABP) of 70-90 mmHg versus an individual strategy targeting ± 10 % of a MABP reference value is feasible. Secondary aims are to test recruitability and to detect challenges or obstacles that would call for changes in the study design.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Large vessel occlusion in anterior circulation in patients deemed treatable with EVT.
• Living independently (mRS < 2) before stroke.
• EVT procedure feasible within 24 hours of symptom onset.

Exclusion criteria

• Contra-indication/allergy to contrast agents, vasopressor agents or anaesthetics.
• Pregnancy.
• Medical condition where blood pressure targeting will be problematic (aorta dissection, etc).
• Participation in another trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Individual blood pressure management arm

Experimental group

Description:

During the EVT procedure(in general anesthesia), mean arterial blood pressure (MABP) during is targeted to remain within +/- 10 % of a reference value using vasoactive drugs and/or fluids

Treatment:

Procedure: Individualized blood pressure management

Standard blood pressure management arm

Active Comparator group

Description:

During the EVT procedure(in general anesthesia), mean arterial blood pressure (MABP) during is targeted to remain within a fixed range of 70-90 mmHg

Treatment:

Procedure: Standard blood pressure management