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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: Liver Transplant; Complications; Pediatric Disease; Hepatic Artery Thrombosis

Treatments: Drug: Low molecular weight heparin; Drug: Ticagrelor Oral Tablet [Brilinta]

Study type: Interventional

Funder types: Other

Identifiers

NCT04946929

KY2021-083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Ticagrelor, 2-3mg/kg, 12h

Experimental group

Description:

2-3mg/kg, q12h, p.o. for 2w

Treatment:

Drug: Ticagrelor Oral Tablet [Brilinta]

low molecular weight heparin

Active Comparator group

Description:

half amount low molecular weight heparin

Treatment:

Drug: Low molecular weight heparin