Transcranial Doppler During Liver Transplantation

April 7, 2022 updated by: Mansoura University

Transcranial Doppler and Neurological Complications After Liver Transplantation

This is a prospective study that would investigate the transcranial doppler (TCD) changes during the living donor liver transplantation and the association between the TCD changes and the post-transplant neurological complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

Participants & Setting:

Intervention & Measurements:

Sample size:

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients scheduled for living donor liver transplantation for whatever the indication at Gastrointestinal surgery center (GISC)

Exclusion Criteria:

  • Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TCD arm
All patients will be evaluated with TCD for prediction of the post-transplant neurological complications
Diagnostic test: Transcranial Doppler

Transcranial Doppler-derived parameters; pulsatility index (PI), resistance index (RI), mean flow velocity (Vmean) will be recorded before induction of anesthesia (T1).

After induction, TCD parameters, Hemodynamic variables including heart rate (HR), invasive mean arterial blood pressure (MAP), and central venous pressure (CVP) together with Arterial blood gases (ABG analysis with values of PH, PCO2, PO2, blood oxygen saturation SO2 and bicarbonate HCO3), end-tidal carbon dioxide (ETCO2) and body temperature will be recorded too. Just before skin incision (T2), at the end of anhepatic phase 5 minutes before reperfusion (T3), 5 minutes after reperfusion (T4) and at the end of surgery (T5).

Postoperatively at ICU, TCD parameters, Hemodynamic variables, and ABG will be obtained 24 hours postoperative (T6) and at discharge from ICU (T7).

Other Names:
  • TCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-transplant Neurological Complication
Time Frame: 28 days after transplantation
incidence of Neurological Complication as a composite outcome (tremors, seizures, demyelination, posterior reversible encephalopathy syndrome, stroke)
28 days after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
flow patterns throughout the transplant surgery and in the ICU
Time Frame: intraoperative and 7 days after transplantion
normal, hyperemic, low-flow, or vasospastic flow by TCD
intraoperative and 7 days after transplantion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Amr M Yassen, MD, Mansoura University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2021

Primary Completion (Anticipated)

November 28, 2023

Study Completion (Anticipated)

April 28, 2024

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.21.09.535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available with the corresponding author at reasonable request. The Data publishing with the manuscript will be discussed later.

IPD Sharing Time Frame

will be updated

IPD Sharing Access Criteria

will be updated

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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