Effect of strategy for blood pressure control on cerebral oxygen balance during aortic coarctation repair: a randomized study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002640-19-BE

Enrollment

Unknown

Registered

2007-08-03

Start date

2007-09-06

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

aortic coarctation requiring surgical correction MedDRA version: 9.1 Level: LLT Classification code 10002894 Term: Aortic coarctation

Interventions

Trade Name: Sevorane Product Name: Sevoflurane Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: Sevoflurane CAS Number: 28523866 Concentration unit: % percent Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All neonates and infants, aged 0 – 18 year, with aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: All patients with an associated cardiac defect

Design outcomes

Primary

Measure	Time frame
Main Objective: investigation of the effect of different blood pressure controlling agents on the cerebral oxygen balance between both brain hemispheres during aortic coarctation repair by using near-infrared technology;Secondary Objective: ;Primary end point(s): mean target blood pressure of 120 to 150 % of the blood pressure before clamping	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026