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

NCT ID: NCT04946929

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2023-03-31

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.

Conditions

Hepatic Artery Thrombosis; Liver Transplant; Complications; Pediatric Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ticagrelor, 2-3mg/kg, 12h

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

Group Type: EXPERIMENTAL

Ticagrelor Oral Tablet [Brilinta]

Intervention Type: DRUG

Ticagrelor, 2-3mg/kg, 12h, p.o.

low molecular weight heparin

half amount low molecular weight heparin

Group Type: ACTIVE_COMPARATOR

Low molecular weight heparin

Intervention Type: DRUG

half amount low molecular weight heparin

Interventions

Ticagrelor Oral Tablet [Brilinta]

Ticagrelor, 2-3mg/kg, 12h, p.o.

Intervention Type: DRUG

Low molecular weight heparin

half amount low molecular weight heparin

Intervention Type: DRUG

Other Intervention Names

Ticagrelor

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Feng, MD. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Chuan Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Xiaosong Chen, MD

Role: STUDY_DIRECTOR

Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Qiang XIA, MD. Ph.D

Role: STUDY_CHAIR

Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Locations

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Countries

China

Central Contacts

Hao Feng, MD. Ph.D

Role: CONTACT

surgeonfeng@live.com

+8615000901110

Other Identifiers

KY2021-083

Identifier Type: -

Identifier Source: org_study_id