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

NCT04946929 | Unknown Phase 3

• 1 other identifier: KY2021-083
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Artery Thrombosis; Liver Transplant; Complications; Pediatric Disease

Outcome Measures

Primary Outcomes (1)

• Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index

  The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)

  3 months

Secondary Outcomes (2)

• High on-treatment platelet reactivity (HPR)

  Two hours after the injection of either active drug or placebo

• Post-operative major bleeding event

  within 72 hours after operation

Study Arms (2)

Ticagrelor, 2-3mg/kg, 12h

EXPERIMENTAL

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

Drug: Ticagrelor Oral Tablet [Brilinta]

low molecular weight heparin

ACTIVE COMPARATOR

half amount low molecular weight heparin

Drug: Low molecular weight heparin

Interventions

Ticagrelor Oral Tablet [Brilinta] DRUG

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

Also known as: Ticagrelor

Ticagrelor, 2-3mg/kg, 12h

Low molecular weight heparin DRUG

half amount low molecular weight heparin

low molecular weight heparin

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age from 2 months to 5 years old.
• voluntary participation in clinical trials, and informed consent;
• Contrast- Enhanced Ultrasonography proved HAT

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, 200127, China

Location

MeSH Terms

Interventions

Ticagrelor; Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Hao Feng, MD. Ph.D

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

  PRINCIPAL INVESTIGATOR

• Chuan Shen, MD

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

  PRINCIPAL INVESTIGATOR

• Xiaosong Chen, MD

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

  STUDY DIRECTOR

• Qiang XIA, MD. Ph.D

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

  STUDY CHAIR

Central Study Contacts

Hao Feng, MD. Ph.D

CONTACT

+8615000901110; surgeonfeng@live.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: July 31, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

CN (1)