Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation

Pediatric Liver Transplantation Clinical Trial

Official title:

Perioperative Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03494595
• Other study ID #: TEG PLT
• Status: Recruiting
• First received: March 27, 2018
• Last updated: April 4, 2018
• Start date: December 2018
• Est. completion date: February 2023

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: Ahmed HH Amin
• Phone: 1060431973
• Email: ahmed.hamada777[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 15 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pre-existing blood disease.

• A history of liver transplantation.

• Multivisceral transplantation.

• Participants' parent/guardian refused to participate in the study.

Related Conditions & MeSH terms

• Pediatric Liver Transplantation

Intervention

Procedure:
• Pediatric Liver transplantation
Pediatric Liver transplantation

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperative, an average of 12 hours
Primary	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.	Postoperative up to 1 week.
Secondary	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.	Preoperative up to 1 day before surgery.
Secondary	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.	In pre-anhepatic stage, an average of 4 hours.
Secondary	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.	In anhepatic stage, an average of 2 hours.
Secondary	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.	After reperfusion, an average of 4 hours.
Secondary	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.	At the end of surgery, an average of 12 hours.
Secondary	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.	Preoperative up to 1 day before surgery.
Secondary	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.	In pre-anhepatic stage, an average of 4 hours.
Secondary	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.	In anhepatic stage, an average of 2 hours.
Secondary	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.	After reperfusion, an average of 4 hours.
Secondary	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.	At the end of surgery, an average of 12 hours.
Secondary	Angle a preoperative.	Angle a, the angle of tangent at 2 mm amplitude (ANG a, in degrees) as detected by thromboelastometry preoperatively.	Preoperative up to 1 day before surgery.
Secondary	Angle a in pre-anhepatic stage.	Angle a, the angle of tangent at 2 mm amplitude (ANG a, in degrees) as detected by thromboelastometry during pre-anhepatic stage.	In pre-anhepatic stage, an average of 4 hours.
Secondary	Angle a in anhepatic stage.	Angle a, the angle of tangent at 2 mm amplitude (ANG a, in degrees) as detected by thromboelastometry during anhepatic stage.	In anhepatic stage, an average of 2 hours.
Secondary	Angle a after reperfusion.	Angle a, the angle of tangent at 2 mm amplitude (ANG a, in degrees) as detected by thromboelastometry after reperfusion.	After reperfusion, an average of 4 hours.
Secondary	Angle a at the end of surgery	Angle a, the angle of tangent at 2 mm amplitude (ANG a, in degrees) as detected by thromboelastometry at the end of surgery.	At the end of surgery, an average of 12 hours.
Secondary	Maximum Clot Firmness preoperative.	Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography preoperatively.	Preoperative up to 1 day before surgery.
Secondary	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.	In pre-anhepatic stage, an average of 4 hours.
Secondary	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.	In anhepatic stage, an average of 2 hours.
Secondary	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.	After reperfusion, an average of 4 hours.
Secondary	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.	At the end of surgery, an average of 12 hours.
Secondary	Warm ischemic time	in minutes	during the surgery, an average of 2 hours
Secondary	Length of ICU stay	in days	after the surgery, an average of 1 month
Secondary	Length of hospital stay	in days	postoperative, an average of 1 month