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

Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Complications; Pediatric Disease; Hepatic Artery Thrombosis
• Intervention / Treatment: Drug: Ticagrelor Oral Tablet [Brilinta]; Drug: 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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hao Feng, MD. Ph.D; Phone Number: +8615000901110; Email: surgeonfeng@live.com

Study Locations

• China
  • Shanghai, China, 200127
    • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ticagrelor, 2-3mg/kg, 12h; 2-3mg/kg, q12h, p.o. for 2w	Drug: Ticagrelor Oral Tablet [Brilinta]; Ticagrelor, 2-3mg/kg, 12h, p.o.; Other Names: Ticagrelor
ACTIVE_COMPARATOR: low molecular weight heparin; half amount low molecular weight heparin	Drug: Low molecular weight heparin; half amount low molecular weight heparin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Hao Feng, MD. Ph.D, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine; Principal Investigator: Chuan Shen, MD, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine; Study Director: Xiaosong Chen, MD, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine; Study Chair: Qiang XIA, MD. Ph.D, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 31, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (ACTUAL): July 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Anticoagulants; Ticagrelor; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: KY2021-083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No