Effect of perioperative Sonoclot monitoring on early thrombosis after pediatric liver transplantation: a prospective observational study

Introduction

Pediatric liver transplantation is the preferred treatment for children suffering from end-stage liver disease (1). The postoperative short-or long-term survival rate has continuously improved, and the survival rate at 1, 5, and 10 years after surgery is as high as 95%, 80%, and 60% (2,3). It is undeniable that there are still some problems after liver transplantation. Large traumas and irritations, such as hepatic failure, prolonged operative time, massive hemorrhage, blood transfusion, and perioperative ischemia-reperfusion injury, can cause coagulation disorders. These disorders may lead to major intraoperative and postoperative blood loss, arrhythmia, thrombosis, and other vascular complications. Furthermore, they can adversely affect postoperative graft function recovery and overall quality of life. Unlike in adults, postoperative thrombosis represents the most serious and common complication in pediatric patients (4). Blood flow signals that are too fast or too slow may have a trend of developing into thrombosis, especially at the anastomotic site. There are many factors that influence thrombosis, among which anastomotic stenosis and hypercoagulability are important factors (5). Therefore, except for surgical technique problems, perioperative coagulation monitoring is frequently performed during liver transplantation in children to guide pro- and anti-coagulant therapies.

Sonoclot analyzer is a point-of-care coagulation monitoring system that assesses the viscoelastic properties of whole blood (6). Sonoclot assesses the whole blood coagulation status and also provides useful information on platelet function (PF) (7). Sonoclot devices are used in situations of abnormal coagulation such as cardiac and liver transplant surgery (8,9). However, the use of Sonoclot in related pediatric liver transplantation, which involves complex coagulopathy, has not been well elucidated. Therefore, in this study, the Sonoclot analyser was used to determine the changes in coagulation function after ischemia-reperfusion, and to explore the optimal coagulation values for reducing postoperative thrombosis. We present this article in accordance with the STROBE reporting checklist (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0351/rc).

Methods

Patients

The study was conducted at a transplant center from September 2019 and May 2021. 200 patients aged 5 months and 2 years who underwent living-donor liver transplantation (LDLT) for biliary atresia were enrolled in this prospective, observational study. Exclusion criteria were as follows: children with congenital heart disease, central nervous system disease, or re-transplantation; patients treated with heparin drugs during surgery; patients with severe arrhythmia, major bleeding and other complications that occurred during the operation. General anesthesia was administered to all patients. Traditional monitoring methods were used to monitor patients’ vital signs during operation among which the invasive monitors included an intra-arterial catheter and a central venous catheter. All data were obtained from the liver transplant and anesthesia records, and the procedures were performed by the same group of surgeons. Intraoperative transfusion of red blood cells and plasma, especially in the anhepatic phase and initial stage of the new liver phase, to maintain hemoglobin concentration and correct coagulation function. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Ethical approval for this study was provided by the Ethics Committee of Tianjin First Central Hospital, Tianjin, China (Chairperson Prof. Chunge Wang) on 13 August 2019 (No. 2019NO94KY). Written informed consent was obtained from eligible guardians. This study has been registered at the Chinese Clinical Trial Registry (ID: ChiCTR1900026125).

Blood coagulation monitoring

According to the previous study, Sonoclot device (Sienco Inc., Arvada, CO, USA) could be used to monitor coagulation (9). Additionally, in the clinic, the coagulation function was routinely monitored in our department by Sonoclot during perioperative liver transplantation especially after reperfusion. It was clarified that coagulation function disorder was exacerbated with the progression of operation. Activated partial thromboplastin time (APTT) was prolonged, platelet count (PLT) and fibrinogen (Fib) were decreased and a rebound peak occurred in the initial phase of new-liver stage. Then, as the new liver function is restored, the coagulation function gradually improves. We found that from 1 h after reperfusion until the end of surgery, the coagulation function trended to stable if there was no other intervention. Therefore, the Sonoclot coagulation monitoring data at 1 h after ischemia-reperfusion was collected, including activation of whole blood clotting time (ACT), clotting rate (CR), and PF. All data were stored on the Sonoclot machine.

Clinical data collection

We collected the following preoperative, intraoperative and postoperative data. The following preoperative variables were included: patient characteristics, pediatric end-stage liver disease model (PELD) scores, serum bilirubin, serum albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and international normalized ratio (INR). Intraoperative data were graft cold ischemia time, anhepatic time, urine output, bleeding volume, blood products as well as the duration of surgery. Postoperative data included the highest AST, ALT, and total bilirubin levels during the first week after operation, the intensive care unit (ICU) stay time, other complications such as mortality, the rate of secondary transplant and abdominal laparotomy one month after transplantation. After discharge from the hospital, the children were followed up regularly through the hospital follow-up center to monitor the children’s condition.

Study endpoints

The primary endpoint was the occurrence of any thrombosis (arterial or venous) within the first week following surgery. Secondary endpoints were other complications including mortality, the rate of secondary transplant and abdominal laparotomy during the first month after transplantation.

Thrombosis diagnostic criteria and management

All hepatic artery anastomoses were performed under microscopic magnification by a single experienced transplant surgeon. Donor hepatic artery anatomy was reviewed from the preprocurement imaging and intraoperative findings. Cases with anatomical variations (e.g., replaced or accessory right/left hepatic arteries) were reconstructed with microsurgical techniques. We followed up and observed the occurrence of thrombosis within one week after surgery. The diagnostic methods for thrombosis were (10): (I) postoperative transaminase and bilirubin levels were important indicators for early diagnosis; (II) angiography was the gold standard for the diagnosis of thrombosis; (III) ultrasound Doppler could effectively detect vascular patency, which was a powerful screening method. The most common manifestations were the loss of blood flow signal or increased resistance index (RI).

Once Doppler ultrasonography reveals absent or abnormal flow parameters, such as hepatic artery resistive index (RI) <0.5 or >0.8, or systolic acceleration time (SAT) >0.08 s, contrast-enhanced ultrasound was performed immediately. If the hepatic artery remains undetectable, computed tomography angiography (CTA) is performed without delay. If CTA suggests thrombosis, urgent interventional hepatic arteriography with thrombolysis or stent placement is performed immediately; open surgical arterial reconstruction is undertaken when necessary (11). In this study, the early state of thrombosis, such as the decreased or altered blood flow velocity, was also regarded as an early sign of thrombosis. According to our previous observations, these abnormal blood flow signals can easily form into thrombosis in the end. Daily ultrasound examination, which was the most important test, was performed to detect the blood flow within one week after surgery in our center.

Intraoperative hemostasis should be ensured thoroughly. Postoperative anticoagulation therapy is initiated on the day of surgery or postoperative day 1, with a regimen of heparin sodium at 20 U/kg·h to maintain an APTT of 60–80 s. Warfarin is bridged on days 4–7, with a target INR of 1.5–2.0 maintained until 3 months postoperatively.

Statistical analysis

All the data were analyzed using SPSS 23.0 software package for Windows (SPSS, Inc., Chicago, IL, USA). Absolute number (n), frequencies, percentages, and mean ± standard deviation (SD) were shown as appropriate to describe the data. The χ² test and the Fisher exact test were used for the categorical variables. Logistic regression models were used to detect the risk factors associated with the Sonoclot variables and thrombosis. Data were reported as odds ratio (OR) with corresponding 95% confidence interval (CI). Receiver operating characteristic (ROC) analysis was used to analyze the effect of Sonoclot parameters on thrombosis. The cutoff value was determined by the maximum Youden index with optimal sensitivity and specificity. P<0.05 was considered statistically significant for all variables.

Post-hoc power analysis was performed using the observed group sample sizes (n=38 for thrombosis group, n=162 for non-thrombosis group) and the observed effect size. The mean ACT difference between groups was 100 s (pooled SD 54.6). With a two-sided α=0.05, the achieved statistical power exceeded 90%, indicating that the observed difference is highly reliable.

Results

Baseline demographics

From September 2019 to May 2021, a total of 238 patients underwent regular coagulation monitoring. Among these patients, 5 cases were re-transplant cases, 10 cases had congenital heart disease or other diseases, 12 patients had massive hemorrhage during or after surgery, and 11 patients were lost to follow-up. Finally, 200 patients met the inclusion criteria in this prospective trial (Figure 1).

Figure 1 The flow chart of the study.

Postoperative complications and outcomes

A total of 38 cases (19%) had thrombosis complications in 200 children within 1 week after surgery. Among them, 23 cases (11.5%) had hepatic artery thrombosis (HAT) and 15 cases (7.5%) had portal vein (PVT) and hepatic vein thrombosis (HVT). Three patients (1.5%) were found to have thrombosis in both arterial and venous blood vessels. Eight patients (4.0%) underwent laparotomy thrombectomy. Three cases died (1.5%, 2 patients died of multiple organ failure caused by HAT, 1 died of acute rejection) within 1 month after operation. Four patients (2%) had to undergo transplantation again because of graft failure. The outcomes were shown in Table 1.

Predisposing factors for thrombosis within 1 week after liver transplantation

According to the complications of thrombosis, we divided the patients into the thrombosis group (n=38) and non-thrombosis group (n=162). Results comparing baseline characteristics and perioperative information between the two groups of patients were shown in Table 2. Patients in the thrombosis group had a younger age, lower body weight, lower height, and a higher PELD score. During the surgery, patients in the thrombosis group had longer anhepatic time and graft cold ischemia time. Patients in the thrombosis group received more plasma (P<0.05). The other variables were not statistically significant between the two groups. We compared the three parameters of the Sonoclot analyser monitored at 1 h after reperfusion and found that there was a difference in ACT between the two groups, and there were no statistical differences in CR and PF between the two groups. ACT was lower in the thrombosis group than that in the non-thrombosis group (178.5±33.2 & 280.4±58.6, P<0.05).

Then we included the meaningful variables (P<0.05) in Table 2 into multivariate regression analysis and found that PELD [OR =1.745, 95% CI: 1.205 to 2.529, P=0.003], graft cold ischemia time [OR =1.072, 95% CI: 1.002 to 1.148, P=0.045] and ACT [OR =0.925, 95% CI: 0.884 to 0.967, P=0.001] were independent risk factors for postoperative thrombosis (Table 3).

The cutoff point of ACT by ROC analysis

The ROC value was highest for the measurements performed at 1 h after reperfusion, and ACT was significantly associated with 1-week thrombosis [Bootstrap area under the curve (AUC): 0.918; 95% CI: 0.872–0.954; P<0.01; Figure 2]. ACT value of 228.5 s was the most appropriate cutoff to predict early thrombosis occurrence with a sensitivity of 94.7% and specificity of 80.2%.

Figure 2 ROC curve analysis of ACT at 1 h after reperfusion. ACT, activated clotting time; AUC, area under the ROC curve; CI, confidence interval; ROC, receiver operating characteristic.

Patients were then classified into 2 groups according to this cutoff value: the lower-ACT group (ACT <228.5 s) and the higher-ACT group (ACT ≥228.5 s). A total of 68 of the 200 patients (34%) had lower ACT. Early thrombosis complications and other outcomes after liver transplantation in children between two groups were depicted in Table 4. As shown, in the lower-ACT group, the overall incidence of thrombosis, HAT and postoperative laparotomy were higher. In addition, the highest level of transaminase (ALT, AST) in lower-ACT group was higher than that in higher-ACT group after surgery within 1 week (Table 4).

Discussion

Pediatric liver transplantation is an important part of clinical liver transplantation for children suffering from end-stage liver disease (12). Recently, data promulgated by a Japanese research team, showed that the graft survival rates at 1, 10, 20, and 30 years were 88.9%, 82.2%, 77.1%, and 75.4% (13). It was the largest cohort study that followed up a total of 3,347 children worldwide to observe the overall survival in children after liver transplantation. The results showed the postoperative survival rate had improved a lot. However, there are still a series of complications after surgery that affect the quality of life. Bleeding and coagulopathy are critical issues complicating pediatric liver transplantation and contributing to morbidity and mortality in cirrhotic children. Vascular complications are common in pediatric liver transplantation (14). In fact, Thrombosis remains the primary cause of early graft failure and re-transplantation within the first 30 d after surgery, and it occurs despite prolongation of standard coagulation assays (4). Vessel anastomosis between donor and recipient is more difficult because the blood vessels do not match well and the blood vessels of the child are thinner than adults (15,16). Perioperative coagulation should not be overcorrected; otherwise thrombosis can easily develop during and after surgery. Thus, it is significant to correct coagulation function accurately. This study found that perioperative coagulation affected the occurrence of postoperative thrombosis complications. The most common vascular complication after surgery was thrombosis. Sonoclot analyzer could be used to monitor coagulation function in pediatric liver transplantation. Sonoclot parameter ACT after ischemia-reperfusion was a risk factor for early postoperative thrombosis. Maintaining ACT above 228.5 s from 1 h after ischemia-reperfusion until the end of surgery was associated with a lower incidence of postoperative thrombosis in this cohort.

Liver is a site of synthesis for most coagulation factors and anticoagulant substances. The special pathophysiological changes in liver transplantation led to a large change in perioperative coagulation function. Children with biliary atresia develop cirrhosis before surgery, affecting the synthesis and release of coagulation factors. Clotting factor production is significantly reduced in perioperative anhepatic phase. The release of toxic substances accumulated from lower part of the body and perfusate of the donor liver after ischemia-reperfusion cause a severe insult to the neohepatic stage liver (17,18). Liver coagulation function drops again. The coagulation function of the body in the early neohepatic stage is the worst. We called this phenomenon the “heparin-like effect” (19). In pediatric-related liver transplantation, plasma infusion is generally used to correct blood coagulation, especially from the anhepatic stage to the early stage of the new liver stage. According to clinical practice, the coagulation function tended to be stable from 1 h after reperfusion to the end of the operation. During anhepatic phase and after ischemia-reperfusion, it is necessary to actively and accurately correct blood coagulation. On the one hand, we need to properly correct coagulation to reduce bleeding. On the other hand, we should not over-correct coagulation to prevent slow blood stasis and thrombosis (20).

HAT is the most common vascular complication after liver transplantation, with an incidence of 6–15%, of which 22.7% requires secondary liver transplantation (21,22). PVT rate is 4–10%, easily leading to portal hypertension (4). In our study, the diagnosis of thrombosis was based on Doppler ultrasound findings, with some cases confirmed by angiography. Patients with markedly abnormal Doppler flow signals (e.g., decreased or altered flow velocity, loss of signal) were classified into the thrombosis group. According to our institutional experience, these ultrasound abnormalities are considered high-risk thrombotic states that warrant active clinical intervention. Therefore, in this study, the incidence rate of patients with thrombosis after surgery was 19%, with the highest incidence of HAT (11.5%). Our HAT incidence (11.5%) was higher than that reported by Gautier et al., who described a single-center experience of hepatic arterial supply impairment in pediatric liver transplant recipients (23). This discrepancy may be explained by differences in study populations, definitions of thrombotic events, or monitoring protocols. Gautier et al. emphasized the importance of timely diagnosis and intervention, which aligns with our institutional practice of using daily Doppler ultrasound and immediate confirmatory imaging for any flow abnormality. There are many reasons for the influence of thrombosis, among which anastomotic stenosis and hypercoagulability are important factors (24). Thus, hypercoagulability during liver transplantation deserves closer attention as thromboembolic events are associated with high morbidity and mortality rates (25).

There are many methods for monitoring coagulation function, including traditional detection of prothrombin time (PT), INR, APTT, etc. Some equipment, such as thromboelastography (TEG) and Sonoclot coagulation analyzer, has been widely used clinically, especially in heart surgery and transplant surgery (26-28). However, the value of these traditional parameters such as PT, APTT has been questioned in the acute perioperative setting because of the delay between blood sampling and obtaining results. Additionally, these tests are carried out on plasma rather than whole blood, and they do not provide much information about PF (29). TEG is widely used in major surgeries such as cardiac surgery and adult liver transplantation because it provides multiple parameters for coagulation monitoring. However, TEG requires specialized personnel, has high costs, and has a long turnaround time, which limits its ability to provide real-time monitoring during the rapidly changing perioperative period of liver transplantation (30). The Sonoclot analyzer is a point-of-care coagulation monitoring system that offers real-time assessment of coagulation status at the bedside with a faster turnaround time. It evaluates whole blood and provides three core parameters: activated clotting time (ACT, reference range 119–195 s), which reflects coagulation factor function; CR (reference range 7–23), which indicates Fib level and the rate of fibrin formation; and PF (reference range 1.5–4.5), which represents PLT-Fib interaction (31). These advantages make Sonoclot particularly suitable for coagulation monitoring in pediatric liver transplantation. Our study proved that Sonoclot devices could be used to guide the monitoring of coagulation function during the perioperative liver transplantation period in children. The most meaningful parameter was ACT. The value of ACT was lower in the thrombosis group, but there were no significant differences in CR and PF between the two groups. These results were consistent with clinical findings. Generally, we just infused fresh frozen plasma, no infusion of Fib, PLTs, etc.

In our multivariate analysis, the higher PELD score, prolonged graft cold ischemia time and lower ACT were identified as independent risk factors for early postoperative thrombosis. A plausible explanation for this observation is that children with lower PELD scores have relatively better preserved synthetic liver function. Consequently, they may carry over more endogenous coagulation factors (synthesized by the native liver) into the immediate post-transplant period. This transient hypercoagulable state may increase the risk of early thrombotic events. In contrast, children with higher PELD scores typically have severely impaired synthetic function, which may lower their coagulation potential post-transplant and reduce immediate thrombotic risk. Regarding prolonged cold ischemia time, longer graft cold ischemia time is known to cause endothelial injury and activation of the coagulation cascade in the graft vasculature. Ischemia-reperfusion injury following graft implantation further amplifies this pro-thrombotic environment by promoting PLT adhesion and reducing endogenous anticoagulant factors (e.g., thrombomodulin). The combination of endothelial damage and activation of the coagulation system likely explains why prolonged cold ischemia time independently contributes to postoperative thrombosis in our cohort. It is very necessary to maintain a state of lower coagulation than normal for pediatric-related LDLT due to special physiological and pathological changes and anatomical features. Therefore, the appropriate coagulation parameters according to Sonoclot devices have always been the focus of our research. Under normal circumstances, Sonoclot analyser shows that the normal value of ACT is 119–195 s. However, in our study, the ACT was maintained at a higher range to reduce postoperative thrombosis. In this experiment, the ROC curve was used to analyse the cut-off value of ACT and found that it was better to maintain the ACT above 228.5 s to reduce the occurrence of thrombosis. This cut-off value exceeded the standard ACT value of the Sonoclot machine (119–195 s), and the AUC was higher than 0.9. The diagnostic effect and reliability were higher. This study focused on the lower threshold of ACT associated with reduced thrombosis risk. In this research, we excluded 12 patients with intraoperative massive hemorrhage, who were biologically most likely to exhibit high ACT levels without thrombosis. Their exclusion may have partially overestimated the apparent protective effect of high ACT against thrombosis. Therefore, our findings are primarily applicable to pediatric recipients without severe intraoperative bleeding, and caution is needed when extrapolating to cases with massive hemorrhage. However, we did not systematically investigate an upper limit of ACT or the associated bleeding risk. Based on our institutional experience, an ACT exceeding 300 s is generally considered to increase the risk of intraoperative and postoperative bleeding. We therefore empirically avoid maintaining ACT above 300 s in clinical practice. The optimal therapeutic window (lower threshold to prevent thrombosis, upper threshold to avoid bleeding) remains undefined. Future prospective studies should specifically investigate the relationship between the upper limit of ACT and hemorrhagic complications, as well as the clinical outcomes of patients with massive hemorrhage who were excluded from this analysis.

Several limitations of this study should be acknowledged. First, our thrombosis rate was higher than reported by other high-volume centers. As discussed earlier, this is primarily because we included Doppler defined high risk flow abnormalities as part of our composite endpoint, rather than requiring angiographic confirmation for all cases. Second, we did not collect data on operative factors known to influence thrombosis risk-such as graft type, anastomosis site, vessel diameter, or the use of magnification devices (microscope vs. loupes). These technical variables may have a stronger impact on early postoperative thrombosis than coagulation parameters alone. Third, ACT was measured only at a single time point (1 h after ischemia-reperfusion). Coagulation function evolves dynamically as graft function recovers, and a single measurement may not fully capture the thrombotic risk over the entire first postoperative week. Future prospective studies with serial Sonoclot monitoring and detailed collection of operative variables are needed to better define the predictors of early thrombosis in pediatric liver transplantation.

Conclusions

In summary, this study identified factors associated with early thrombosis in children after liver transplantation, including the ACT level after ischemia-reperfusion. In this cohort, maintaining ACT above the normal range was associated with a lower incidence of early postoperative thrombosis. Prospective randomized studies are needed to establish a causal therapeutic target.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0351/rc

Data Sharing Statement: Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0351/dss

Peer Review File: Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0351/prf

Funding: This work was financially supported by the Tianjin Key Clinical Specialty Construction Project, Tianjin Key Medical Construction Project (No. TJYXZDXK-3-022C), and Spring Foundation of Tianjin First Central Hospital (No. 2019CF31).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0351/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Ethical approval for this study was provided by the Ethics Committee of Tianjin First Central Hospital, Tianjin, China (Chairperson Prof. Chunge Wang) on 13 August 2019 (No. 2019NO94KY). Written informed consent was obtained from eligible guardians.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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