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

NCT ID: NCT03494595

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2023-02-28

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.

Conditions

Pediatric Liver Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Thrombosis

Patients who will develop thrombosis perioperatively

Pediatric Liver transplantation

Intervention Type: PROCEDURE

Pediatric Liver transplantation

No thrombosis

Patients who will not develop thrombosis perioperatively

Pediatric Liver transplantation

Intervention Type: PROCEDURE

Pediatric Liver transplantation

Interventions

Pediatric Liver transplantation

Pediatric Liver transplantation

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hamada Hamed

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed HH Amin

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer

Fatma AA Ahmed

Role: STUDY_CHAIR

Professor

Eman AE Ahmed

Role: STUDY_DIRECTOR

Assistant professor

Ghada MA Abdelhamid

Role: STUDY_DIRECTOR

Lecturer

Locations

Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed HH Amin

Role: CONTACT

ahmed.hamada777@gmail.com

1060431973 ext. +20

Facility Contacts

Ahmed HH Amin

Role: primary

ahmed.hamada777@gmail.com

1060431973 ext. +20

Other Identifiers

TEG PLT

Identifier Type: -

Identifier Source: org_study_id