Uni- versus bilateral cerebral perfusion in hemiarch replacement – a prospective randomized controlled trial

Uni- versus bilateral cerebral perfusion in hemiarch replacement – a prospective randomized controlled trial - UBI-ARCH

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037491

Enrollment

126

Registered

2025-11-11

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I71

Interventions

Group 1: Patients undergoing non-emergent aortic hemiarch replacement with unilateral antegrade cerebral perfusion. This does not significantly prolong or alter the operation performed. Only the type

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with ascending aortic and proximal aortic arch aneurysm with indication for non-emergent surgical replacement according to the 2023 EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ.

Exclusion criteria

Exclusion criteria: Patients younger than 18 years Severe calcification of the aortic arch or supra aortic vessels Pregnant and breastfeeding women Patients unable to give informed consent (psychiatric disease, forms of dementia, substance abuse, etc.) Acute neurological deficit (< 3 months) Patients without informed consent

Design outcomes

Primary

Measure	Time frame
Recruitment rates (feasibility endpoint)	—

Secondary

Measure	Time frame
Stroke (VARC-3) All-cause mortality until day 30 Number and rate of acute kidney injury until day 30 Number and rate of delirium until day 30 Number and rate of cognitive dysfunction until day 30 Number and rate Pulmonary Complications (respiratory failure, prolonged ventilation >48 hours) until day 30 Number and rate of conversion from unilateral to bilateral cerebral perfusion (in the unilateral group).	—

Measure

Time frame

Stroke (VARC-3) All-cause mortality until day 30 Number and rate of acute kidney injury until day 30 Number and rate of delirium until day 30 Number and rate of cognitive dysfunction until day 30 Number and rate Pulmonary Complications (respiratory failure, prolonged ventilation >48 hours) until day 30 Number and rate of conversion from unilateral to bilateral cerebral perfusion (in the unilateral group).

—

Countries

Germany

Contacts

Public ContactJoseph Kletzer

Universitäts Herzzentrum Freiburg - Bad Krozingen

joseph.kletzer@uniklinik-freiburg.de+49 7633 402 6226

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026