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CompletedNCT03945942NIRS_GREFFEUpdated Mar 18, 2021

Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

An interventional study of Near infrared spectroscopy with INVOS device and Near infrared spectroscopy with Foresight device in Liver Transplant; Complications, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2021-03-18.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
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Study summary

Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.

Read the detailed description

Hyperbilirubinaemia may interfere with oximetry values as measured by Near Infrared Spectroscopy devices. The number of wave lengths used by different devices can influence the oximetry values in adult patients. This has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.The study will compare cerebral and somatic oximetry values measured by two different Near infrared spectroscopy devices (FORESIGHT and INVOS) and analyse the influence of bilirubin levels on these differences.

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Conditions studied

  • Liver Transplant; Complications

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03

In context

Hyperbilirubinemia

135 studies on the registry are indexed under Hyperbilirubinemia; 18 are open to participants now.

This study's enrollment of 33 is below the median of 84 across 80 interventional studies indexed under Hyperbilirubinemia.

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Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution
  • Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure

Exclusion criteria

Exclusion Criteria:

  • refusal of the patient or his parents to consent
  • known brain or Neurological pathology
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Other
    Pediatric liver transplant patients

    Using somatic and cerebral Near infrared spectroscopy devices

    Device: Near infrared spectroscopy with INVOS device · Device: Near infrared spectroscopy with Foresight device

Interventions

  • DeviceNear infrared spectroscopy with INVOS device

    somatic and cerebral oximetry by INVOS in pediatric liver transplantation

  • DeviceNear infrared spectroscopy with Foresight device

    somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

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What researchers measure

Primary outcomes

  1. influence of chromophores such as bilirubin on oximetry values provided by two different devices

    measure of oximetry values by two different devices at different time points in function of serum bilirubin levels

    Time frame: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)

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Study locations

1 site
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03945942
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
May 10, 2019
Start date
Mar 15, 2019
Primary completion
Oct 15, 2020
Completion
Oct 15, 2020
Last update
Mar 18, 2021

Study contacts

Natalia MAGASICH-AIROLA, MD
principal investigator · natalia.magasich@uclouvain.be

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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