Clinical trial NCT03494595: Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
Official title: Perioperative Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Liver Transplantation
Keywords: Pediatric Liver Transplantation, Thromboelastometry
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatrics undergoing liver transplantation

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative thrombotic events (hepatic artery or portal vein thrombosis)
timeFrame: Intraoperative, an average of 12 hours
measure: Thrombotic events (hepatic artery or portal vein thrombosis)
timeFrame: Postoperative up to 1 week.
Secondary outcomes:
measure: Coagulation Time preoperative.
timeFrame: Preoperative up to 1 day before surgery.
measure: Coagulation Time in pre-anhepatic stage.
timeFrame: In pre-anhepatic stage, an average of 4 hours.
measure: Coagulation Time in anhepatic stage.
timeFrame: In anhepatic stage, an average of 2 hours.
measure: Coagulation Time after reperfusion.
timeFrame: After reperfusion, an average of 4 hours.
measure: Coagulation Time at the end of surgery.
timeFrame: At the end of surgery, an average of 12 hours.
measure: Clot Formation Time preoperative
timeFrame: Preoperative up to 1 day before surgery.
measure: Clot Formation Time in pre-anhepatic stage.
timeFrame: In pre-anhepatic stage, an average of 4 hours.
measure: Clot Formation Time in anhepatic stage.
timeFrame: In anhepatic stage, an average of 2 hours.
measure: Clot Formation Time after reperfusion.
timeFrame: After reperfusion, an average of 4 hours.
measure: Clot Formation Time at the end of surgery
timeFrame: At the end of surgery, an average of 12 hours.
measure: Angle α preoperative.
timeFrame: Preoperative up to 1 day before surgery.
measure: Angle α in pre-anhepatic stage.
timeFrame: In pre-anhepatic stage, an average of 4 hours.
measure: Angle α in anhepatic stage.
timeFrame: In anhepatic stage, an average of 2 hours.
measure: Angle α after reperfusion.
timeFrame: After reperfusion, an average of 4 hours.
measure: Angle α at the end of surgery
timeFrame: At the end of surgery, an average of 12 hours.
measure: Maximum Clot Firmness preoperative.
timeFrame: Preoperative up to 1 day before surgery.
measure: Maximum Clot Firmness in pre-anhepatic stage.
timeFrame: In pre-anhepatic stage, an average of 4 hours.
measure: Maximum Clot Firmness in anhepatic stage.
timeFrame: In anhepatic stage, an average of 2 hours.
measure: Maximum Clot Firmness after reperfusion.
timeFrame: After reperfusion, an average of 4 hours.
measure: Maximum Clot Firmness at the end of surgery.
timeFrame: At the end of surgery, an average of 12 hours.
measure: Warm ischemic time
timeFrame: during the surgery, an average of 2 hours
measure: Length of ICU stay
timeFrame: after the surgery, an average of 1 month
measure: Length of hospital stay
timeFrame: postoperative, an average of 1 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assistant Lecturer
name: Ahmed HH Amin
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor
name: Fatma AA Ahmed
role: STUDY_CHAIR
affiliation: Assistant professor
name: Eman AE Ahmed
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Ghada MA Abdelhamid
role: STUDY_DIRECTOR
References: