ClinicalTrials.gg
Status unknownNCT05144451Updated Apr 14, 2022

Transcranial Doppler During Liver Transplantation

An interventional study of Transcranial Doppler in Liver Transplantation, Ultrasonography, Doppler, Transcranial and Complication, Postoperative, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.

Sponsored by Mansoura University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Objectives:

Participants \& Setting:

Intervention \& Measurements:

Sample size:

02

Conditions studied

  • Liver Transplantation
  • Ultrasonography, Doppler, Transcranial
  • Complication, Postoperative
  • Neurologic Deficits
03

In context

Postoperative Complications

1,267 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.

This study's planned enrollment of 100 is below the median of 117 across 710 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    TCD arm

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

    Diagnostic Test: Transcranial Doppler

Interventions

  • Diagnostic testTranscranial 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).

    Also known as: TCD

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What researchers measure

Primary outcomes

  1. Post-transplant Neurological Complication

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

    Time frame: 28 days after transplantation

Secondary outcomes

  1. flow patterns throughout the transplant surgery and in the ICU

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

    Time frame: intraoperative and 7 days after transplantion

07

Study locations

1 of 1 sites recruiting
  • Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit
    Al Mansurah, Dakahlia Governorate 35516, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data will be available with the corresponding author at reasonable request. The Data publishing with the manuscript will be discussed later.

Time frame: will be updated

Access criteria: will be updated

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Nov 2023, 24 months after the start.

Of 377 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 24 months is above that.

Counting every sponsor, half of 381 studies reached it within 22 months; a quarter within 8 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2021
First posted
Dec 3, 2021
StartActual
Nov 28, 2021
Primary completionEst.
Nov 28, 2023
CompletionEst.
Apr 28, 2024
Last update
Apr 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05144451
Responsible party
Sponsor
First posted
Dec 3, 2021
Start date
Nov 28, 2021
Primary completion
Nov 28, 2023 (estimated)
Completion
Apr 28, 2024 (estimated)
Last update
Apr 14, 2022

Study contacts

Moataz M Emara, MD, EDAIC
Contact
mm.emara@mans.edu.eg
+201064048848
Kareem M Abozeid, MSc
Contact
kareemmohabozeid27@gmail.com
1557442411 ext. +20
Amr M Yassen, MD
study director · Mansoura University Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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