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Transcranial Doppler During Liver Transplantation

Primary Purpose

Liver Transplantation, Ultrasonography, Doppler, Transcranial, Complication, Postoperative

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Transcranial Doppler

About this trial

This is an interventional screening trial for Liver Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation UnitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TCD arm

Arm Description

All patients will be evaluated with TCD for prediction of the post-transplant neurological complications

Outcomes

Primary Outcome Measures

Post-transplant Neurological Complication

incidence of Neurological Complication as a composite outcome (tremors, seizures, demyelination, posterior reversible encephalopathy syndrome, stroke)

Secondary Outcome Measures

flow patterns throughout the transplant surgery and in the ICU

normal, hyperemic, low-flow, or vasospastic flow by TCD

Full Information

NCT ID

NCT05144451

First Posted

November 22, 2021

Last Updated

April 7, 2022

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05144451

Brief Title

Transcranial Doppler During Liver Transplantation

Official Title

Transcranial Doppler and Neurological Complications After Liver Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 28, 2021 (Actual)

Primary Completion Date

November 28, 2023 (Anticipated)

Study Completion Date

April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

Objectives: Participants & Setting: Intervention & Measurements: Sample size:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Transplantation, Ultrasonography, Doppler, Transcranial, Complication, Postoperative, Neurologic Deficits

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

A single-arm trial involving 100 patients undergoing living donor liver transplantation; all will be examined using transcranial doppler to find out its predictive value on post-transplant neurological deficits.

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TCD arm

Arm Type

Experimental

Arm Description

All patients will be evaluated with TCD for prediction of the post-transplant neurological complications

Intervention Type

Diagnostic Test

Intervention Name(s)

Transcranial Doppler

Other Intervention Name(s)

TCD

Intervention Description

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).

Primary Outcome Measure Information:

Title

Post-transplant Neurological Complication

Description

incidence of Neurological Complication as a composite outcome (tremors, seizures, demyelination, posterior reversible encephalopathy syndrome, stroke)

Time Frame

28 days after transplantation

Secondary Outcome Measure Information:

Title

flow patterns throughout the transplant surgery and in the ICU

Description

normal, hyperemic, low-flow, or vasospastic flow by TCD

Time Frame

intraoperative and 7 days after transplantion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moataz M Emara, MD, EDAIC

Phone

+201064048848

mm.emara@mans.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Kareem M Abozeid, MSc

Phone

1557442411

Ext

+20

kareemmohabozeid27@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amr M Yassen, MD

Organizational Affiliation

Mansoura University Faculty of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit

City

Mansoura

State/Province

Dakahlia

ZIP/Postal Code

35516

Country

Egypt

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Transcranial Doppler During Liver Transplantation

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