NCT03945942

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

March 4, 2019

Last Update Submit

March 17, 2021

Conditions

Liver Transplant; Complications

Outcome Measures

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

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

Study Arms (1)

Pediatric liver transplant patients

OTHER

Using somatic and cerebral Near infrared spectroscopy devices

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

Interventions

Near infrared spectroscopy with INVOS deviceDEVICE

somatic and cerebral oximetry by INVOS in pediatric liver transplantation

Pediatric liver transplant patients
Near infrared spectroscopy with Foresight deviceDEVICE

somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

Pediatric liver transplant patients

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Natalia MAGASICH-AIROLA, MD

    natalia.magasich@uclouvain.be

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

May 10, 2019

Study Start

March 15, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)