Comparing the efficacy and safety of thromboprophylaxis with enoxaparin versus normal saline after liver transplantation: randomized clinical trial.
Xie, K., et al.British Journal of Surgery 2025; 112(2): 01.
Aims
This study aimed to assess the effect of prophylactic anticoagulation with enoxaparin in deceased donor liver transplant (DDLT) recipients.
Interventions
Participants were randomised to either the enoxaparin group or the normal saline group.
Participants
462 orthotopic DDLT patients (18-70 years).
Outcomes
The primary endpoints were the incidence of venous thrombosis (efficacy outcome) and incidence of major bleeding (safety outcome). The secondary efficacy endpoints were all-cause mortality and the incidence of portal vein thrombosis (PVT) and deep vein thrombosis (DVT).
Follow-up
90 days posttransplantation
CET Conclusions
Thromboprophylaxis following liver transplantation (LT) is not standard practice as liver disease causes coagulation defects and its use can cause perioperative bleeding complications. This randomised control trial investigated the efficacy and safety of using prophylactic enoxaparin in patients who had LT. 383 patients were randomised to receive either prophylactic enoxaparin or normal saline for 1 week. The primary outcomes included rates of deep vein thrombosis (DVT), portal vein thrombosis (PVT) and major haemorrhage. The authors found no significant difference in rates of thrombosis and an increase rate of bleeding complications. In addition to the primary investigators (and clinical decision makers) not being blinded, the trial is limited by small patient numbers – as PVT is relatively rare, the study is underpowered to detect differences between the two groups. Additionally, the authors’ definition of major haemorrhage includes perioperative blood loss that does not require transfusion or surgical intervention. Given that the consequences of PVT are more severe than clinically insignificant blood loss, the findings of this study cannot be generalised and prophylactic thromboprophylaxis strategies should continue to be individualised.
Data analysis
Strict intention-to-treat analysis
Trial registration
ChiCTR2000032441