Individualized Blood Pressure Management During Endovascular Stroke Treatment

Conditions

Acute Ischemic Stroke

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).

Chen M, Sauer LD, Potreck A, Kieser M, Bendszus M, Ringleb P, Möhlenbruch M, Schönenberger S.

2025-11-24

10.1177/17562864251391837

Effect of Individualized Versus Standardized Blood Pressure Management During Endovascular Stroke Treatment on Clinical Outcome: A Randomized Clinical Trial

Min Chen, Jan Meis, Arne Potreck, Lukas D. Sauer, Meinhard Kieser et al. (10 authors)

Stroke2023-09-2116 citations

10.1161/strokeaha.123.044062

Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial.

Maïer B, Gory B, Chabanne R, Tavernier B, Balanca B, Audibert G, Thion LA, Le Guen M, Geeraerts T, Calviere L, Degos V, Lapergue B, Richard S, Djarallah A, Mophawe O, Boursin P, Le Cossec C, Blanc R, Piotin M, Mazighi M, Gayat E, DETERMINE Investigators.

2022-07-2610 citations

10.1186/s13063-022-06538-9

Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial

Min Chen, Dorothea Kronsteiner, Markus Möhlenbruch, Meinhard Kieser, Martin Bendszus et al. (9 authors)

European Stroke Journal2021-03-0421 citations

10.1177/23969873211000879

Interventions

PROCEDUREINDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION

The individual target range is defined as: bSBP ± 10 mmHg. The lowest possible SBP target range is 100-120 mmHg. The highest SBP target range is determined on the basis of whether patients receive concurrent IV fibrinolytic therapy or not. In patients where IV fibrinolytic therapy is applied, the highest SBP range is 160-180 mmHg, in patients without concurrent fibrinolytic therapy the highest SBP range is 180-200 mmHg.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame	Description
Functional outcome 90 days after stroke onset	90 days	modified Rankin scale (mRS) after 90 days dichotomized 0-2 by (favorable outcome) to 3-6 (unfavorable outcome).

Secondary

Measure	Time frame	Description
Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission	24 hours	\[NIHSS on admission - NIHSS after 24 hours\]
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]	12-36 hours	Infarction size 12-36 hours after symptom onset
Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion]	Duration of thrombectomy procedure up to 240 minutes	Duration of thrombectomy procedure
Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion]	Duration of thrombectomy procedure up to 240 minutes	Duration of thrombectomy procedure

Countries

Germany

Outcome results

None listed