Liver Transplant; ComplicationsNIRS_GREFFENCT03945942
Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices
A study testing Near infrared spectroscopy with INVOS device and Near infrared spectroscopy with Foresight device in people with Liver Transplant; Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Near infrared spectroscopy with INVOS device and Near infrared spectroscopy with Foresight device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- refusal of the patient or his parents to consent
- known brain or Neurological pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation
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.
- Conditions
- Liver Transplant; Complications
- Being tested
- Near infrared spectroscopy with INVOS device, Near infrared spectroscopy with Foresight device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopy with INVOS deviceDevice
somatic and cerebral oximetry by INVOS in pediatric liver transplantation
Near infrared spectroscopy with Foresight deviceDevice
somatic and cerebral oximetry with Foresight device in pediatric liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Pediatric liver transplant patients | Other | Using somatic and cerebral Near infrared spectroscopy devices Receives: Device: Near infrared spectroscopy with INVOS device; Device: Near infrared spectroscopy with Foresight device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start15 Mar 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia MAGASICH-AIROLA, MD, Principal investigator, natalia.magasich@uclouvain.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945942
- Sponsor's protocol ID
- 2018/07NOV/413
- Acronym
- NIRS_GREFFE
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation
- ClinicalTrials.gov ID
- NCT03945942
- Acronym / sponsor ID
- NIRS_GREFFE / 2018/07NOV/413
- Conditions
- Liver Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric liver transplant patients | Other | Device: Near infrared spectroscopy with INVOS device, Device: Near infrared spectroscopy with Foresight deviceUsing somatic and cerebral Near infrared spectroscopy devices |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- refusal of the patient or his parents to consent
- known brain or Neurological pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopy with INVOS devicesomatic and cerebral oximetry by INVOS in pediatric liver transplantation | Device | Pediatric liver transplant patients |
| Near infrared spectroscopy with Foresight devicesomatic and cerebral oximetry with Foresight device in pediatric liver transplantation | Device | Pediatric liver transplant patients |
Primary outcome
influence of chromophores such as bilirubin on oximetry values provided by two different devices
Time frame: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)
measure of oximetry values by two different devices at different time points in function of serum bilirubin levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia MAGASICH-AIROLA, MD principal investigator
natalia.magasich@uclouvain.be
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near infrared spectroscopy with INVOS device and Near infrared spectroscopy with Foresight device in people with Liver Transplant; Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
influence of chromophores such as bilirubin on oximetry values provided by two different devices (time frame: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.