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

NCT03494595 | Unknown

• 1 other identifier: TEG PLT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Liver Transplantation

Keywords

Pediatric Liver Transplantation, Thromboelastometry

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (23)

• 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.

Study Arms (2)

Thrombosis

Patients who will develop thrombosis perioperatively

Procedure: Pediatric Liver transplantation

No thrombosis

Patients who will not develop thrombosis perioperatively

Procedure: Pediatric Liver transplantation

Interventions

Pediatric Liver transplantation PROCEDURE

Pediatric Liver transplantation

No thrombosis; Thrombosis

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatrics undergoing liver transplantation

You may qualify if:

• 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.

You may not qualify if:

• Pre-existing blood disease.
• A history of liver transplantation.
• Multivisceral transplantation.
• Participants' parent/guardian refused to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71516, Egypt

RECRUITING

Study Officials

• Ahmed HH Amin

  Assistant Lecturer

  PRINCIPAL INVESTIGATOR

• Fatma AA Ahmed

  Professor

  STUDY CHAIR

• Eman AE Ahmed

  Assistant professor

  STUDY DIRECTOR

• Ghada MA Abdelhamid

  Lecturer

  STUDY DIRECTOR

Central Study Contacts

Ahmed HH Amin

CONTACT

1060431973; ahmed.hamada777@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 11, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

EG (1)