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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor, 2-3mg/kg, 12h | Experimental | 2-3mg/kg, q12h, p.o. for 2w |
|
| low molecular weight heparin | Active Comparator | half amount low molecular weight heparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor Oral Tablet [Brilinta] | Drug | Ticagrelor, 2-3mg/kg, 12h, p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index | The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Post-operative major bleeding event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Feng, MD. Ph.D | Contact | +8615000901110 | surgeonfeng@live.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Low molecular weight heparin | Drug | half amount low molecular weight heparin |
|
post-operative major bleeding defined as HAT related bleeding
| within 72 hours after operation |
| 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |