Back to resultsTicagrelor in Post-transplant Patients With Pediatric Hepatic Artery Thrombosis (HAT) (Tip-HAT)
Primary Purpose
Hepatic Artery Thrombosis, Liver Transplant; Complications, Pediatric Disease
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ticagrelor Oral Tablet [Brilinta]
Low molecular weight heparin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Artery Thrombosis
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
Sites / Locations
- Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor, 2-3mg/kg, 12h
low molecular weight heparin
Arm Description
2-3mg/kg, q12h, p.o. for 2w
half amount low molecular weight heparin
Outcomes
Primary Outcome Measures
Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index
The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)
Secondary Outcome Measures
High on-treatment platelet reactivity (HPR)
HPR defined as platelet reactivity index (PRI) ≥50% using VASP analysis
Post-operative major bleeding event
post-operative major bleeding defined as HAT related bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04946929
Brief Title
Ticagrelor in Post-transplant Patients With Pediatric Hepatic Artery Thrombosis (HAT)
Acronym
Tip-HAT
Official Title
Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Artery Thrombosis, Liver Transplant; Complications, Pediatric Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor, 2-3mg/kg, 12h
Arm Type
Experimental
Arm Description
2-3mg/kg, q12h, p.o. for 2w
Arm Title
low molecular weight heparin
Arm Type
Active Comparator
Arm Description
half amount low molecular weight heparin
Intervention Type
Drug
Intervention Name(s)
Ticagrelor Oral Tablet [Brilinta]
Other Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor, 2-3mg/kg, 12h, p.o.
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Intervention Description
half amount low molecular weight heparin
Primary Outcome Measure Information:
Title
Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index
Description
The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
High on-treatment platelet reactivity (HPR)
Description
HPR defined as platelet reactivity index (PRI) ≥50% using VASP analysis
Time Frame
Two hours after the injection of either active drug or placebo
Title
Post-operative major bleeding event
Description
post-operative major bleeding defined as HAT related bleeding
Time Frame
within 72 hours after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Feng, MD. Ph.D
Phone
+8615000901110
Email
surgeonfeng@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Feng, MD. Ph.D
Organizational Affiliation
Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chuan Shen, MD
Organizational Affiliation
Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaosong Chen, MD
Organizational Affiliation
Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qiang XIA, MD. Ph.D
Organizational Affiliation
Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ticagrelor in Post-transplant Patients With Pediatric Hepatic Artery Thrombosis (HAT)
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