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

Liver Transplant; Complications Clinical Trial

— Tip-HAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04946929
• Other study ID #: KY2021-083
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 31, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2021
• Source: RenJi Hospital
• Contact: Hao Feng, MD. Ph.D
• Phone: +8615000901110
• Email: surgeonfeng[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Pediatric Disease
• Thrombosis

Intervention

Drug:
• Ticagrelor Oral Tablet [Brilinta]
Ticagrelor, 2-3mg/kg, 12h, p.o.
• Low molecular weight heparin
half amount low molecular weight heparin

Locations

Country	Name	City	State
China	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index	The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)	3 months
Secondary	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
Secondary	Post-operative major bleeding event	post-operative major bleeding defined as HAT related bleeding	within 72 hours after operation