Transplant Trial Watch

Clinical study of argatroban for preventing vascular thrombosis in the early period after pediatric living-related donor liver transplantation.

Na, L. and H. Jindong.

Pediatric Transplantation 2020; 24(2): e13654.


Aims
This study aimed to compare the effectiveness of heparin versus argatroban in preventing vascular thrombosis during the early period following pediatric living-related donor liver transplantation (LRDLT).

Interventions
Participants were randomly split into either the heparin group or the argatroban group.

Participants
84 pediatric LRDLT patients.

Outcomes
The outcomes of interest were antithrombin III (AT-III) activity, activated partial thromboplastin time (APTT), international normalized ratio (INR), and the incidence of vascular thrombosis and adverse reactions.

Follow-up
N/A

CET Conclusions
Thrombotic complications after liver transplantation can be catastrophic and the risk is increased in paediatric transplantation. However, the impact of this particular study on this clinical issue is limited. It is a clinical trial in paediatric liver transplantation with only 2 authors. 84 recipients were included, all of whom were receiving transplants from their parents and the primary outcome is not declared clearly. Patients were randomised to 2 arms of the study in a 3:1 ratio (heparin or argatroban), but the method of randomisation is not explained. No power calculation is presented to justify or explain the size of study, or the reason for the 3:1 group allocation and there is no description of blinding. Both heparin and argatroban were only given for the first 5 days after surgery. Antithrombin-III levels were similar between the groups but it is not clear that the study was adequately powered for this outcome. There was a significant difference in APTT, being longer with argatroban, and more thrombotic complications in the heparin group, but strong conclusions cannot be drawn from this small study with no description of randomisation or blinding.

Trial registration
N/A

Funding source
Not reported