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| Name | Class |
|---|---|
| Aalborg University | OTHER |
| Klinikum Kassel | OTHER |
| University Hospital Heidelberg | OTHER |
| Sahlgrenska University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual blood pressure management arm | Experimental | 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 |
|
| Standard blood pressure management arm | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized blood pressure management | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death) | Functional outcome measure | Assessed up to 3 months after endovascular treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate (percentage) | Percentage of admitted patients scheduled for EVT who is enrolled in the study | Assessed up 3 months after endovascular treatment |
| Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range |
| Measure | Description | Time Frame |
|---|---|---|
| Criteria for continuation to the definitive trial | The two arms are distinguishable on 3-month mRS with a trend statistical significant p-value below 0.1 or all of the following:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mads Rasmussen, MD, PhD | Department of Anesthesia, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
This is a pilot study and the data may be made available to other researchers upon request
Data may be shared after publication of main study results within a period of 5 years after publication
No criteria
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| Rigshospitalet, Denmark | OTHER |
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)
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| Standard blood pressure management | Procedure | During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg |
|
...Percentage of time outside the blood pressure targets |
| Assessed 3 months after endovascular treatment |
| Data completeness (percentage) | Percentage of complete patient data study records | Assessed up to 3 months after endovascular treatment |
| Degree of reperfusion | 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) | Assessed up to 3 months after endovascular treatment |
| Assessed up to 3 months after endovascular treatment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |