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CORTEX

Cerebral Oxygenation and BIS monitoring during Regional Perfusion in Transplant Donors, prospective study - The CORTEX

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58465
Enrollment
50
Registered
2026-03-11
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

abdominal normothermic regional perfusion in donation after cardiac death

Interventions

NIRS Sensors:NIRS sensors (MESPERE, Canada) are non-invasive monitoring devices used to assess tissue oxygenation levels, particularly during surgical procedures or critical care. These sensors employ

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult (16 years and older) cardiac death donors undergoing an abdominal normothermic regional perfusion organ retrieval procedure.

Exclusion criteria

Exclusion criteria: Known allergy to substances in the sensor adhesives or gels.

Design outcomes

Primary

MeasureTime frame
The main endpoint is an absolute rise of 10 points of cerebral oximeter and BIS index from baseline during the period of aNRP.

Secondary

MeasureTime frame
To determine the trend and timing of COX and BIS after start of abdominal regional perfusion compared to baseline after cardiac death in donor retrieval procedures, and to identify potential factors associated with increase or trend in COX / BIS monitoring.To determine variations in baseline COX and BIS index in the deceased donor.To determine if COX and BIS index give similar results in trend and absolute values.

Countries

Netherlands

Contacts

Public ContactM Bieze

Erasmus MC, Universitair Medisch Centrum Rotterdam

m.waller-bieze@erasmusmc.nl0107040704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026