Acute Ischemic Stroke
Conditions
Keywords
Endovascular therapy, Blood pressure, Anesthesia
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.
Interventions
PROCEDUREStandard blood pressure management
During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg
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
Sponsors
Aalborg University
Klinikum Kassel
University Hospital Heidelberg
Sahlgrenska University Hospital
Rigshospitalet, Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
The study will be performed as a single center study, conducted at Aarhus University Hospital, Denmark. In the randomization process patients are stratified according to NIHSS (0-17 or \> 17) and age (18-65 or \> 66)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death) | Assessed up to 3 months after endovascular treatment | Functional outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate (percentage) | Assessed up 3 months after endovascular treatment | Percentage of admitted patients scheduled for EVT who is enrolled in the study |
| Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range | Assessed 3 months after endovascular treatment | ...Percentage of time outside the blood pressure targets |
| Data completeness (percentage) | Assessed up to 3 months after endovascular treatment | Percentage of complete patient data study records |
| Degree of reperfusion | Assessed up to 3 months after endovascular treatment | Thrombolysis in Cerebral Infarction Score (TICI) score. The TICI score is a grading scale for angiographic outcomes rankin from 0 (no perfusion) to 3(complete perfusion) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Criteria for continuation to the definitive trial | Assessed up to 3 months after endovascular treatment | The two arms are distinguishable on 3-month mRS with a trend statistical significant p-value below 0.1 or all of the following: * Drop out rate is less than 10% * Data completion is above 90% * (A cumulated duration of 10 minutes outside the MABP targets is allowed) Additional cumulated time outside the respective MABP target range is on average less than 8% of the duration of the intervention |
Countries
Denmark
Outcome results
None listed