IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke

NCT ID: NCT04749251

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-01-16

Brief Summary

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.

Detailed 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individual blood pressure management arm

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

Group Type: EXPERIMENTAL

Individualized blood pressure management

Intervention Type: PROCEDURE

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

Standard blood pressure management arm

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

Group Type: ACTIVE_COMPARATOR

Standard blood pressure management

Intervention Type: PROCEDURE

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

Interventions

Individualized blood pressure management

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

Intervention Type: PROCEDURE

Standard blood pressure management

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University

OTHER

Sponsor Role: collaborator

Klinikum Kassel

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mads Rasmussen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

IDEAL BP Feasibility Study

Identifier Type: -

Identifier Source: org_study_id