Clinical trial NCT04946929: Ticagrelor in Post-transplant Patients With Pediatric Hepatic Artery Thrombosis (HAT)
Official title: Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatic Artery Thrombosis
Liver Transplant; Complications
Pediatric Disease
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index
timeFrame: 3 months
Secondary outcomes:
measure: High on-treatment platelet reactivity (HPR)
timeFrame: Two hours after the injection of either active drug or placebo
measure: Post-operative major bleeding event
timeFrame: within 72 hours after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Hao Feng, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Chuan Shen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Xiaosong Chen, MD
role: STUDY_DIRECTOR
affiliation: Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Qiang XIA, MD. Ph.D
role: STUDY_CHAIR
References: