NCT05822570

Brief Summary

Hemoglobin (Hb) is the molecule responsible for the transport of oxygen (O2) to the tissues in mammals. The p50 and the Hill coefficient (HC) best describe the ODC. The interaction between Hb and O2 can be influenced by many agents and conditions like temperature, pH, pCO2 and 2,3-diphosphoglycerate (2,3-DPG). During liver transplantation numerous profound physiological changes occur, linked to the different stages of the surgical procedure. Previous studies in humans and animals undergoing liver transplantation have shown that while the ODC seems preserved during preparation and the anhepatic phase, a left shift of the ODC occurs after reperfusion . This left shift of the ODC could imply a decreased release of oxygen to the tissues, probably worsening hemodynamic instability. With this pilot study the investigator aim to measure ODCs at baseline and at different stages during orthotopic liver transplantation in patients in order to get deeper understanding of oxygen delivery and supply during liver transplantation surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

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

April 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

March 26, 2025

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

April 6, 2023

Last Update Submit

March 24, 2025

Conditions

Keywords

Liver TransplantationOxygen dissociation curve

Outcome Measures

Primary Outcomes (1)

  • Oxygen Dissocation Curve

    Oxgen delivery curve characteristics based on p50 values, Hill-coefficient and 2,3 DPG

    24 hours

Interventions

ODC will be assessed at 5 timepoints: T0 after installation of arterial catheter, T1 before clamping of the liver, T2 5-10 min before reperfusion of the liver graft, T3 45 min after reperfusion, T4 1 h after T3 or at end of surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for orthotopic liver transplantation

You may qualify if:

  • Patien scheduled for LTX
  • Age 18 years to 99 years
  • Signed informed content form.

You may not qualify if:

  • Known hemoglobinopathy
  • Need for more than 3 packed erythrocytes before assessment at T4.
  • preoperative predicted need for more than 3 based on study team
  • MELD score \< 10
  • stay at high attitude (\>3000 m) for more days over the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 20, 2023

Study Start

May 1, 2023

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

March 26, 2025

Record last verified: 2024-11

Locations