Perioperative Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric Liver Transplantation
- Sponsor
- Assiut University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Intraoperative thrombotic events (hepatic artery or portal vein thrombosis)
- Last Updated
- 8 years ago
Overview
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.
Investigators
Ahmed Hamada Hamed
Assistant Lecturer
Assiut University
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Coagulation Time preoperative.(Preoperative up to 1 day before surgery.)
- Coagulation Time in pre-anhepatic stage.(In pre-anhepatic stage, an average of 4 hours.)
- Coagulation Time in anhepatic stage.(In anhepatic stage, an average of 2 hours.)
- Coagulation Time after reperfusion.(After reperfusion, an average of 4 hours.)
- Coagulation Time at the end of surgery.(At the end of surgery, an average of 12 hours.)
- Clot Formation Time preoperative(Preoperative up to 1 day before surgery.)
- Clot Formation Time after reperfusion.(After reperfusion, an average of 4 hours.)
- Clot Formation Time at the end of surgery(At the end of surgery, an average of 12 hours.)
- Angle α preoperative.(Preoperative up to 1 day before surgery.)
- Angle α in pre-anhepatic stage.(In pre-anhepatic stage, an average of 4 hours.)
- Clot Formation Time in pre-anhepatic stage.(In pre-anhepatic stage, an average of 4 hours.)
- Clot Formation Time in anhepatic stage.(In anhepatic stage, an average of 2 hours.)
- Angle α after reperfusion.(After reperfusion, an average of 4 hours.)
- Angle α at the end of surgery(At the end of surgery, an average of 12 hours.)
- Angle α in anhepatic stage.(In anhepatic stage, an average of 2 hours.)
- Maximum Clot Firmness preoperative.(Preoperative up to 1 day before surgery.)
- Maximum Clot Firmness in pre-anhepatic stage.(In pre-anhepatic stage, an average of 4 hours.)
- Maximum Clot Firmness in anhepatic stage.(In anhepatic stage, an average of 2 hours.)
- Length of hospital stay(postoperative, an average of 1 month)
- Maximum Clot Firmness after reperfusion.(After reperfusion, an average of 4 hours.)
- Maximum Clot Firmness at the end of surgery.(At the end of surgery, an average of 12 hours.)
- Warm ischemic time(during the surgery, an average of 2 hours)
- Length of ICU stay(after the surgery, an average of 1 month)