Liver TransplantationNCT05144451
Transcranial Doppler During Liver Transplantation
A study testing Transcranial Doppler in people with Liver Transplantation and Ultrasonography, Doppler, Transcranial, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Ultrasonography, Doppler, Transcranial, Complication, Postoperative
- What is being tested?
- Transcranial Doppler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2021to 28 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients scheduled for living donor liver transplantation for whatever the indication at Gastrointestinal surgery center (GISC)
Who cannot join
- Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: 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.
Read the detailed description
Objectives:
Participants \& Setting:
Intervention \& Measurements:
Sample size:
- Conditions
- Liver Transplantation, Ultrasonography, Doppler, Transcranial, Complication, Postoperative, Neurologic Deficits
- Being tested
- Transcranial Doppler
- Medical subject headings
- Postoperative Complications, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial DopplerDiagnostic test
Also called TCD
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).
| Study group | Role | What they receive |
|---|---|---|
| TCD arm | Experimental | All patients will be evaluated with TCD for prediction of the post-transplant neurological complications Receives: Diagnostic Test: Transcranial Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-transplant Neurological Complication
incidence of Neurological Complication as a composite outcome (tremors, seizures, demyelination, posterior reversible encephalopathy syndrome, stroke)
Measured: 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
Measured: intraoperative and 7 days after transplantion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start28 Nov 2021
- Primary completion28 Nov 2023 (estimated)
- Study completion28 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr M Yassen, MD, Study director, Mansoura University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144451
- Sponsor's protocol ID
- MD.21.09.535
- Status last verified
- Apr 2022
- First submitted
- 22 Nov 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available with the corresponding author at reasonable request. The Data publishing with the manuscript will be discussed later.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler and Neurological Complications After Liver Transplantation
- ClinicalTrials.gov ID
- NCT05144451
- Acronym / sponsor ID
- MD.21.09.535
- Conditions
- Liver Transplantation, Ultrasonography, Doppler, Transcranial, Complication, Postoperative, Neurologic Deficits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 28 Nov 2023 (estimated)
- Study completion
- 28 Apr 2024 (estimated)
- First posted
- 3 Dec 2021 (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.
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:
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| TCD arm | Experimental | Diagnostic Test: Transcranial DopplerAll patients will be evaluated with TCD for prediction of the post-transplant neurological complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients scheduled for living donor liver transplantation for whatever the indication at Gastrointestinal surgery center (GISC)
Key exclusion criteria (1 listed)
- Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery
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 |
|---|---|---|
| Transcranial DopplerAlso: TCDTranscranial 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). | Diagnostic test | TCD arm |
Primary outcome
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)
1 secondary outcome
flow patterns throughout the transplant surgery and in the ICU
Time frame: intraoperative and 7 days after transplantion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Yes. Data will be available with the corresponding author at reasonable request. The Data publishing with the manuscript will be discussed later.
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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.
Amr M Yassen, MD study director
Mansoura University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Doppler in people with Liver Transplantation and Ultrasonography, Doppler, Transcranial, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moataz M Emara, MD, EDAIC (+201064048848, mm.emara@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-transplant Neurological Complication (time frame: 28 days after transplantation). 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 14 Apr 2022.