Hepatic Artery Thrombosis, Liver Transplant; Complications, Pediatric Disease
Conditions
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.
Interventions
Ticagrelor, 2-3mg/kg, 12h, p.o.
DRUGLow molecular weight heparin
half amount low molecular weight heparin
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index | 3 months | The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative major bleeding event | within 72 hours after operation | post-operative major bleeding defined as HAT related bleeding |
| 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 |
Countries
China
Contacts
Primary ContactHao Feng, MD. Ph.D
Outcome results
None listed