Who is sponsoring NCT04578288?

NCT04578288 is sponsored by University Hospital Heidelberg.

What condition does NCT04578288 study?

NCT04578288 studies Acute Ischemic Stroke.

Is NCT04578288 still recruiting?

NCT04578288 is currently completed. Last updated 8 November 2022.

Last reviewed 2022-11-08 · How we verify

NCT04578288: INDIVIDUATE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Individualized Blood Pressure Management During Endovascular Stroke Treatment

Completed NA Last updated 8 November 2022

What this trial tests

NA trial testing INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION in Acute Ischemic Stroke in 250 participants. Completed in 21 October 2022.

Timeline

1 October 2020

Primary endpoint
21 October 2022

21 October 2022

Quick facts

Lead sponsor	University Hospital Heidelberg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	1 October 2020
Primary completion	21 October 2022
Estimated completion	21 October 2022
Sites	1 location across Germany

Drugs / interventions tested

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

Conditions studied

Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

University Hospital Heidelberg

Who can join

18 and older, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Effect of Individualized Versus Standardized Blood Pressure Management During Endovascular Stroke Treatment on Clinical Outcome: A Randomized Clinical Trial.
Chen M, Meis J, Potreck A, Sauer LD, et al · · 2023 · cited 15× · PMID 37732489 · DOI 10.1161/strokeaha.123.044062
Adjunctive cytoprotective therapies in acute ischemic stroke: a systematic review.
Mulder IA, van Bavel ET, de Vries HE, Coutinho JM. · · 2021 · cited 15× · PMID 34666786 · DOI 10.1186/s12987-021-00280-1
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, et al · · 2022 · cited 11× · PMID 35883180 · DOI 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.
Chen M, Kronsteiner D, Möhlenbruch MA, Kieser M, et al · · 2021 · cited 10× · PMID 34746424 · DOI 10.1177/23969873211000879
Hemodynamic Status During Endovascular Stroke Treatment: Association of Blood Pressure with Functional Outcome.
Chen M, Kronsteiner D, Pfaff J, Schieber S, et al · · 2021 · cited 10× · PMID 34142339 · DOI 10.1007/s12028-021-01229-w
Association of hemodynamic variability during endovascular stroke treatment with functional outcome and parenchymal hemorrhage.
Chen M, Sauer LD, Potreck A, Kieser M, et al · · 2025 · PMID 41306441 · DOI 10.1177/17562864251391837

Verify or expand the search:

Other recruiting trials for Acute Ischemic Stroke

Currently open trials in the same condition.

NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
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NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
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Other University Hospital Heidelberg trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04578288 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Heidelberg
Last refreshed: 8 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04578288.

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