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

A

Assiut University

Status

Unknown

Conditions

Pediatric Liver Transplantation

Treatments

Procedure: Pediatric Liver transplantation

Study type

Observational

Funder types

Other

Identifiers

NCT03494595
TEG PLT

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

3 months to 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Thrombosis
Description:
Patients who will develop thrombosis perioperatively
Treatment:
Procedure: Pediatric Liver transplantation
No thrombosis
Description:
Patients who will not develop thrombosis perioperatively
Treatment:
Procedure: Pediatric Liver transplantation

Trial contacts and locations

1

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Central trial contact

Ahmed HH Amin

Data sourced from clinicaltrials.gov

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