Ticagrelor in Post-transplant Patients With Pediatric Hepatic Artery Thrombosis (HAT)

Phase 3

• Conditions: Hepatic Artery Thrombosis; Liver Transplant; Complications; Pediatric Disease
• Interventions: Drug: Low molecular weight heparin; Drug: Ticagrelor Oral Tablet [Brilinta]

• Registration Number: NCT04946929
• Lead Sponsor: RenJi Hospital

Brief Summary

Hepatic artery thrombosis (HAT) represents a major cause of graft loss and mortality after Pediatric liver transplantation. Ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster onset of action and greater platelet inhibition) was used to treat patients with pediatric post-transplant hepatic artery thrombosis (HAT) compared to low molecular weight heparin.

Detailed Description

In pediatric patients with post-transplant hepatic artery thrombosis (HAT) , low molecular weight heparin is a commonly used method. Ticagrelor, a direct-acting and reversible ADP receptor antagonist, is now the most commonly used ADP receptor antagonist in the treatment of coronary diseases. Compared to its predecessor clopidogrel, the pharmacokinetic profil of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days. The present study is to evaluate the safety and efficacy of Ticagrelor in pediatirc receipt with post-operative HAT.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Last Update Submitted: 2021-06-23
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01
• Study Start: 2021-07-31
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age from 2 months to 5 years old.
• voluntary participation in clinical trials, and informed consent;
• Contrast- Enhanced Ultrasonography proved HAT

Exclusion Criteria

• History of sensitivity to study medications or any of their excipients
• Renal failure (eGFR <30 or requiring dialysis)
• A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
• Prior stroke
• Active pathological bleeding
• History of intracranial haemorrhage
• Life expectancy <12 months based on investigator's judgement
• Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular [AV)] block) unless already treated with a permanent pacemaker
• Anemia (hematocrit < 27%)
• Platelet count < 100,000/ml
• Concomitant use of strong CYP 3A inhibitors or inducers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low molecular weight heparin	Low molecular weight heparin	half amount low molecular weight heparin
Ticagrelor, 2-3mg/kg, 12h	Ticagrelor Oral Tablet [Brilinta]	2-3mg/kg, q12h, p.o. for 2w

Primary Outcome Measures

Name	Time	Method
Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index	3 months	The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)

Secondary Outcome Measures

Name	Time	Method
High on-treatment platelet reactivity (HPR)	Two hours after the injection of either active drug or placebo	HPR defined as platelet reactivity index (PRI) ≥50% using VASP analysis
Post-operative major bleeding event	within 72 hours after operation	post-operative major bleeding defined as HAT related bleeding

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China