Pediatric Liver TransplantationNCT03494595
Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
An observational study of Pediatric Liver Transplantation, run by Assiut University at 1 site in Egypt.
Trial summary
The study aims to correlate the perioperative results of a device called thromboelastogram, which is used to detect coagulation abnormalities, with thrombotic complications during pediatric recipient liver transplantation. Read more about this study
- Who is it for?
- Ages 3 months to 15 years
- Conditions the study is for
- Pediatric Liver Transplantation
- What is being tested?
- Pediatric Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2018to Feb 2023
- Phase
- Observational
- 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 3 months to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatrics undergoing liver transplantation
Who may be able to join
- Male or female participant must be between 3 months and 15 years of age.
- Participant is a recipient of a first liver allograft from living donors.
- Participant is a single-organ recipient (liver only).
- Participants' parent/guardian is capable of understanding the purposes and risks of the study and must sign an informed consent for the study.
Who cannot join
- Pre-existing blood disease.
- A history of liver transplantation.
- Multivisceral transplantation.
- Participants' parent/guardian refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71516
Ahmed HH Amin, 1060431973 ext. +20, ahmed.hamada777@gmail.com
About this study
Official title: Perioperative Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
The study aims to correlate the perioperative results of a device called thromboelastogram, which is used to detect coagulation abnormalities, with thrombotic complications during pediatric recipient liver transplantation.
Read the detailed description
Pediatric patients undergoing liver transplant are at risk for significant bleeding and thrombotic complications. Studies in both pediatric and adult cohorts estimate an incidence of thrombotic events in up to 26% of cases. Hepatic artery and portal vein thrombosis (PVT) are reported at rates of 5-15% in pediatric cohorts, which is three to four times the incidence in adults. Bleeding estimates are harder to quantify given variability in the definition of major bleeding, but range from approximately 5 to 9%.The contribution of bleeding to morbidity is difficult to quantify, but thrombotic complications are known to reduce graft survival and contribute significantly to adverse outcomes, with mortality rates approaching 50% in those with hepatic artery thrombosis.
Thromboelastometry offers rapid, comprehensive, and global clinical assessment of the patients' coagulation status, as demonstrated by several studies.
Little data exists in the use of thromboelastography (TEG) in pediatric liver transplantation. In 2011, Curiel et al implemented pre-transplant TEGs for patients listed for liver transplantation. The invistigators sought to examine if there were any correlations with preoperative hypercoagulable indices on the TEG and postoperative thrombotic complications.The invistigators have identified that a preoperative hypercoagulable TEG portends to thrombotic complications in pediatric liver transplant patients. Further studies are needed to explore perioperative management strategies for high risk patients to prevent the development of postoperative thrombotic complications based upon preoperative TEG studies. That's why the invistigators will study the perioperative thromboelastometry as a predictor of thrombotic complications during pediatric recipient liver transplantation.
- Conditions
- Pediatric Liver Transplantation
- Being tested
- Pediatric Liver transplantation
- Keywords
- Pediatric Liver Transplantation, Thromboelastometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Liver transplantationProcedure or surgery
Pediatric Liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Thrombosis | Patients who will develop thrombosis perioperatively Receives: Procedure: Pediatric Liver transplantation | |
| No thrombosis | Patients who will not develop thrombosis perioperatively Receives: Procedure: Pediatric Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative thrombotic events (hepatic artery or portal vein thrombosis)
Any documented thrombus by imaging or clinical diagnosis made by direct observation during a surgical procedure. This includes both venous and arterial thromboembolic events.
Measured: Intraoperative, an average of 12 hours
Thrombotic events (hepatic artery or portal vein thrombosis)
Patients will be screened for hepatic thrombosis regularly with liver Doppler ultrasound during the first week postoperatively, with confirmatory imaging based on identified clinical or imaging concerns.
Measured: Postoperative up to 1 week.
Secondary outcomes (23)
Coagulation Time preoperative.
Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry preoperatively.
Measured: Preoperative up to 1 day before surgery.
Coagulation Time in pre-anhepatic stage.
Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry during pre-anhepatic stage.
Measured: In pre-anhepatic stage, an average of 4 hours.
Coagulation Time in anhepatic stage.
Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry during anhepatic stage.
Measured: In anhepatic stage, an average of 2 hours.
Coagulation Time after reperfusion.
Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry after reperfusion.
Measured: After reperfusion, an average of 4 hours.
Coagulation Time at the end of surgery.
Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry at the end of surgery.
Measured: At the end of surgery, an average of 12 hours.
Clot Formation Time preoperative
Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry preoperatively.
Measured: Preoperative up to 1 day before surgery.
Clot Formation Time in pre-anhepatic stage.
Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry during pre-anhepatic stage.
Measured: In pre-anhepatic stage, an average of 4 hours.
Clot Formation Time in anhepatic stage.
Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry during anhepatic stage.
Measured: In anhepatic stage, an average of 2 hours.
Clot Formation Time after reperfusion.
Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry after reperfusion.
Measured: After reperfusion, an average of 4 hours.
Clot Formation Time at the end of surgery
Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry at the end of surgery.
Measured: At the end of surgery, an average of 12 hours.
Angle α preoperative.
Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry preoperatively.
Measured: Preoperative up to 1 day before surgery.
Angle α in pre-anhepatic stage.
Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry during pre-anhepatic stage.
Measured: In pre-anhepatic stage, an average of 4 hours.
Angle α in anhepatic stage.
Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry during anhepatic stage.
Measured: In anhepatic stage, an average of 2 hours.
Angle α after reperfusion.
Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry after reperfusion.
Measured: After reperfusion, an average of 4 hours.
Angle α at the end of surgery
Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry at the end of surgery.
Measured: At the end of surgery, an average of 12 hours.
Maximum Clot Firmness preoperative.
Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography preoperatively.
Measured: Preoperative up to 1 day before surgery.
Maximum Clot Firmness in pre-anhepatic stage.
Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography during pre-anhepatic stage.
Measured: In pre-anhepatic stage, an average of 4 hours.
Maximum Clot Firmness in anhepatic stage.
Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography during anhepatic stage.
Measured: In anhepatic stage, an average of 2 hours.
Maximum Clot Firmness after reperfusion.
Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography after reperfusion.
Measured: After reperfusion, an average of 4 hours.
Maximum Clot Firmness at the end of surgery.
Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography at the end of surgery.
Measured: At the end of surgery, an average of 12 hours.
Warm ischemic time
in minutes
Measured: during the surgery, an average of 2 hours
Length of ICU stay
in days
Measured: after the surgery, an average of 1 month
Length of hospital stay
in days
Measured: postoperative, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamada Hamed, Assiut University
- Investigators
- Ahmed HH Amin, Principal investigator, Assistant LecturerFatma AA Ahmed, Study chair, ProfessorEman AE Ahmed, Study director, Assistant professorGhada MA Abdelhamid, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494595
- Sponsor's protocol ID
- TEG PLT
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
- ClinicalTrials.gov ID
- NCT03494595
- Acronym / sponsor ID
- TEG PLT
- Conditions
- Pediatric Liver Transplantation
- Keywords
- Pediatric Liver Transplantation, Thromboelastometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 11 Apr 2018 (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.
The study aims to correlate the perioperative results of a device called thromboelastogram, which is used to detect coagulation abnormalities, with thrombotic complications during pediatric recipient liver transplantation.
Detailed description
Pediatric patients undergoing liver transplant are at risk for significant bleeding and thrombotic complications. Studies in both pediatric and adult cohorts estimate an incidence of thrombotic events in up to 26% of cases. Hepatic artery and portal vein thrombosis (PVT) are reported at rates of 5-15% in pediatric cohorts, which is three to four times the incidence in adults. Bleeding estimates are harder to quantify given variability in the definition of major bleeding, but range from approximately 5 to 9%.The contribution of bleeding to morbidity is difficult to quantify, but thrombotic complications are known to reduce graft survival and contribute significantly to adverse outcomes, with mortality rates approaching 50% in those with hepatic artery thrombosis.
Thromboelastometry offers rapid, comprehensive, and global clinical assessment of the patients' coagulation status, as demonstrated by several studies.
Little data exists in the use of thromboelastography (TEG) in pediatric liver transplantation. In 2011, Curiel et al implemented pre-transplant TEGs for patients listed for liver transplantation. The invistigators sought to examine if there were any correlations with preoperative hypercoagulable indices on the TEG and postoperative thrombotic complications.The invistigators have identified that a preoperative hypercoagulable TEG portends to thrombotic complications in pediatric liver transplant patients. Further studies are needed to explore perioperative management strategies for high risk patients to prevent the development of postoperative thrombotic complications based upon preoperative TEG studies. That's why the invistigators will study the perioperative thromboelastometry as a predictor of thrombotic complications during pediatric recipient liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombosis | – | Procedure: Pediatric Liver transplantationPatients who will develop thrombosis perioperatively |
| No thrombosis | – | Procedure: Pediatric Liver transplantationPatients who will not develop thrombosis perioperatively |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatrics undergoing liver transplantation
Key inclusion criteria (4 listed)
- Male or female participant must be between 3 months and 15 years of age.
- Participant is a recipient of a first liver allograft from living donors.
- Participant is a single-organ recipient (liver only).
- Participants' parent/guardian is capable of understanding the purposes and risks of the study and must sign an informed consent for the study.
Key exclusion criteria (4 listed)
- Pre-existing blood disease.
- A history of liver transplantation.
- Multivisceral transplantation.
- Participants' parent/guardian refused to participate in the study.
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 |
|---|---|---|
| Pediatric Liver transplantationPediatric Liver transplantation | Procedure or surgery | No thrombosis, Thrombosis |
Primary outcome
Intraoperative thrombotic events (hepatic artery or portal vein thrombosis)
Time frame: Intraoperative, an average of 12 hours
Any documented thrombus by imaging or clinical diagnosis made by direct observation during a surgical procedure. This includes both venous and arterial thromboembolic events.
Thrombotic events (hepatic artery or portal vein thrombosis)
Time frame: Postoperative up to 1 week.
Patients will be screened for hepatic thrombosis regularly with liver Doppler ultrasound during the first week postoperatively, with confirmatory imaging based on identified clinical or imaging concerns.
23 secondary outcomes
Coagulation Time preoperative.
Time frame: Preoperative up to 1 day before surgery.
Coagulation Time in pre-anhepatic stage.
Time frame: In pre-anhepatic stage, an average of 4 hours.
Coagulation Time in anhepatic stage.
Time frame: In anhepatic stage, an average of 2 hours.
Coagulation Time after reperfusion.
Time frame: After reperfusion, an average of 4 hours.
Coagulation Time at the end of surgery.
Time frame: At the end of surgery, an average of 12 hours.
Clot Formation Time preoperative
Time frame: Preoperative up to 1 day before surgery.
Clot Formation Time in pre-anhepatic stage.
Time frame: In pre-anhepatic stage, an average of 4 hours.
Clot Formation Time in anhepatic stage.
Time frame: In anhepatic stage, an average of 2 hours.
Clot Formation Time after reperfusion.
Time frame: After reperfusion, an average of 4 hours.
Clot Formation Time at the end of surgery
Time frame: At the end of surgery, an average of 12 hours.
Angle α preoperative.
Time frame: Preoperative up to 1 day before surgery.
Angle α in pre-anhepatic stage.
Time frame: In pre-anhepatic stage, an average of 4 hours.
Angle α in anhepatic stage.
Time frame: In anhepatic stage, an average of 2 hours.
Angle α after reperfusion.
Time frame: After reperfusion, an average of 4 hours.
Angle α at the end of surgery
Time frame: At the end of surgery, an average of 12 hours.
Maximum Clot Firmness preoperative.
Time frame: Preoperative up to 1 day before surgery.
Maximum Clot Firmness in pre-anhepatic stage.
Time frame: In pre-anhepatic stage, an average of 4 hours.
Maximum Clot Firmness in anhepatic stage.
Time frame: In anhepatic stage, an average of 2 hours.
Maximum Clot Firmness after reperfusion.
Time frame: After reperfusion, an average of 4 hours.
Maximum Clot Firmness at the end of surgery.
Time frame: At the end of surgery, an average of 12 hours.
Warm ischemic time
Time frame: during the surgery, an average of 2 hours
Length of ICU stay
Time frame: after the surgery, an average of 1 month
Length of hospital stay
Time frame: postoperative, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
Related trials for Pediatric Liver Transplantation
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
Recruiting
Health Advocate for Children After Liver Transplant
Pediatric Liver Transplanted Recipients
RecruitingObservational study
A Survey on Growth Development in Children After Liver Transplantation
Growth, Development in Pediatric Liver Transplant Recipients
Active, not recruitingObservational study
Social & Contextual Impact on Children Undergoing Liver Transplantation
Liver Transplantation, Liver Diseases
RecruitingObservational study
VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients
Hepatic Disorders, Intestinal Failure-associated Liver Disease
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.
Ahmed HH Amin principal investigator
Assistant Lecturer
Fatma AA Ahmed study chair
Professor
Eman AE Ahmed study director
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Liver Transplantation, run by Assiut 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 4 inclusion and 4 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 11 Apr 2018. 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 Ahmed HH Amin (1060431973 ext. +20, ahmed.hamada777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative thrombotic events (hepatic artery or portal vein thrombosis) (time frame: Intraoperative, an average of 12 hours). The study lists 2 primary outcomes in all. 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 11 Apr 2018; AzTrials last refreshed its copy on 2 Nov 2026.