Clinical trial NCT04578288: Individualized Blood Pressure Management During Endovascular Stroke Treatment
Official title: Individualized Blood Pressure Management During Endovascular Treatment of Acute Ischemic Stroke Under Procedural Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Functional outcome 90 days after stroke onset
timeFrame: 90 days
Secondary outcomes:
measure: Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission
timeFrame: 24 hours
measure: 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]
timeFrame: 12-36 hours
measure: Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion]
timeFrame: Duration of thrombectomy procedure up to 240 minutes
measure: Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion]
timeFrame: Duration of thrombectomy procedure up to 240 minutes
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Neurology, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
References:
citation: Rasmussen M, Schonenberger S, Henden PL, Valentin JB, Espelund US, Sorensen LH, Juul N, Uhlmann L, Johnsen SP, Rentzos A, Bosel J, Simonsen CZ; SAGA collaborators. Blood Pressure Thresholds and Neurologic Outcomes After Endovascular Therapy for Acute Ischemic Stroke: An Analysis of Individual Patient Data From 3 Randomized Clinical Trials. JAMA Neurol. 2020 May 1;77(5):622-631. doi: 10.1001/jamaneurol.2019.4838.
citation: Lowhagen Henden P, Rentzos A, Karlsson JE, Rosengren L, Sundeman H, Reinsfelt B, Ricksten SE. Hypotension During Endovascular Treatment of Ischemic Stroke Is a Risk Factor for Poor Neurological Outcome. Stroke. 2015 Sep;46(9):2678-80. doi: 10.1161/STROKEAHA.115.009808. Epub 2015 Jul 14.
citation: Schonenberger S, Uhlmann L, Ungerer M, Pfaff J, Nagel S, Klose C, Bendszus M, Wick W, Ringleb PA, Kieser M, Mohlenbruch MA, Bosel J. Association of Blood Pressure With Short- and Long-Term Functional Outcome After Stroke Thrombectomy: Post Hoc Analysis of the SIESTA Trial. Stroke. 2018 Jun;49(6):1451-1456. doi: 10.1161/STROKEAHA.117.019709. Epub 2018 May 2.
citation: Whalin MK, Halenda KM, Haussen DC, Rebello LC, Frankel MR, Gershon RY, Nogueira RG. Even Small Decreases in Blood Pressure during Conscious Sedation Affect Clinical Outcome after Stroke Thrombectomy: An Analysis of Hemodynamic Thresholds. AJNR Am J Neuroradiol. 2017 Feb;38(2):294-298. doi: 10.3174/ajnr.A4992. Epub 2016 Nov 3.
citation: Petersen NH, Ortega-Gutierrez S, Wang A, Lopez GV, Strander S, Kodali S, Silverman A, Zheng-Lin B, Dandapat S, Sansing LH, Schindler JL, Falcone GJ, Gilmore EJ, Amin H, Cord B, Hebert RM, Matouk C, Sheth KN. Decreases in Blood Pressure During Thrombectomy Are Associated With Larger Infarct Volumes and Worse Functional Outcome. Stroke. 2019 Jul;50(7):1797-1804. doi: 10.1161/STROKEAHA.118.024286. Epub 2019 Jun 4.
citation: Chen M, Kronsteiner D, Mohlenbruch MA, Kieser M, Bendszus M, Wick W, Nagel S, Ringleb PA, Schonenberger S. Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) - An explorative randomized controlled trial. Eur Stroke J. 2021 Sep;6(3):276-282. doi: 10.1177/23969873211000879. Epub 2021 Mar 4.