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Aprotinin and tranexamic acid show varying efficacy for hemostasis in neonatal cardiac surgeryTrial Shows Aprotinin May Reduce Blood Loss in Infant Heart Surgery

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Key Takeaway
Note that TXA is the optimal intervention for mortality, while aprotinin shows high efficacy for reducing blood loss.

This network meta-analysis evaluated various hemostatic strategies, including aprotinin (APR), epsilon-aminocaproic acid (EACA), and tranexamic acid (TXA), in 4,556 patients undergoing neonatal and infant cardiac surgery involving cardiopulmonary bypass. The analysis compared these agents against several blood component therapies to assess outcomes such as 24-hour blood loss, transfusion requirements, and mortality.

The study identified aprotinin as the optimal strategy for multiple clinical endpoints: 24-hour blood loss (SUCRA=99.15%), platelet transfusion requirements (SUCRA=82.19%), fresh frozen plasma requirements (SUCRA=84.82%), re-sternotomy for hemostasis (SUCRA=72.85%), risk of thrombosis (SUCRA=79.13%), and renal dysfunction (SUCRA=72.61%). Conversely, EACA was identified as the most effective strategy for reducing red blood cell transfusion needs (SUCRA=69.04%), while TXA was associated with the optimal outcome for mortality (SUCRA=84.77%).

Several limitations were noted, including regulatory restrictions and evidence constraints regarding aprotinin use. Additionally, the efficacy of blood component therapies compared to no intervention remains uncertain as most comparisons were against active comparators rather than placebo. Clinically, TXA is considered a practical first-line alternative, while aprotinin should be used with caution due to its specific regulatory and evidence limitations.

Researchers analyzed data from 27 different studies involving over 4,500 infants and newborns undergoing heart surgery. The study looked at various ways to manage bleeding, including medications like aprotinin, tranexamic acid, and epsilon-aminocaproic acid, as well as blood component therapies.

The analysis found that aprotinin was associated with lower blood loss compared to other treatments like fresh frozen plasma or fibrinogen concentrate. It also appeared to be an effective strategy for reducing the need for platelet transfusions and lowering the risk of certain complications like renal dysfunction. However, tranexamic acid was identified as the most effective option specifically for reducing mortality.

You should keep in mind that this study is a network meta-analysis, which means it looks at links between treatments rather than proving one causes another. Additionally, some medications have regulatory restrictions that limit how they can be used. Because of these factors and the limited data on some therapies, doctors must still weigh all risks and benefits carefully before choosing a treatment.

What this means for you:
Aprotinin may reduce blood loss in infant heart surgery, but its use is limited by certain regulatory constraints.

Common questions

What is the main benefit of using aprotinin in infant heart surgery?

The study found that aprotinin was associated with lower 24-hour blood loss compared to fresh frozen plasma, fibrinogen concentrate, and prothrombin complex concentrate. It was also identified as an optimal strategy for reducing platelet transfusion requirements and the risk of renal dysfunction.

Is tranexamic acid used for these patients?

Yes, tranexamic acid is considered a practical first-line alternative. The study specifically identified tranexamic acid as the optimal intervention for reducing mortality in infants undergoing heart surgery involving cardiopulmonary bypass.

Are there any risks or limitations to these treatments?

While antifibrinolytic agents generally have an acceptable safety profile, aprotinin use is currently limited by regulatory restrictions and evidence constraints. Additionally, it remains uncertain how effective blood component therapies are when compared to no treatment at all.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedJun 2026
View Original Abstract ↓
BackgroundEffective hemostatic management remained a critical challenge in neonatal and infant cardiac surgery with cardiopulmonary bypass (CPB), and a systematic review and network meta-analysis (NMA) had not been conducted to evaluate optimal strategy selection for this vulnerable population.MethodsWe systematically searched PubMed, Web of Science, Cochrane Library, and Embase from inception to December 3, 2025. We use bivariate analysis and NMA with random effects. We use the surface beneath the cumulative ranking curve (SUCRA) to display the order of interventions.ResultsOf the 8,280 records screened, 27 studies involving 4,556 patients were included. Aprotinin (APR) was identified as the optimal hemostatic strategy for reducing 24-hour blood loss (SUCRA=99.15%), platelet (PLT) (SUCRA=82.19%) and fresh frozen plasma (FFP) (SUCRA=84.82%) transfusion requirements, re-sternotomy for hemostasis (SUCRA=72.85%), and risks of thrombosis (SUCRA=79.13%) and renal dysfunction (SUCRA=72.61%). ε-aminocaproic acid (EACA) was found to be the most effective strategy for reducing red blood cell (RBC) transfusion needs (SUCRA=69.04%). Tranexamic acid (TXA) emerged as the optimal intervention for reducing mortality (SUCRA=84.77%).ConclusionAntifibrinolytic agents may demonstrated significant hemostatic efficacy and a generally acceptable safety profile in neonatal and infant cardiac surgery with CPB. Among these agents, while APR showed the highest efficacy, its use is constrained by regulatory restrictions and evidence limitations; therefore, it should be used with caution. TXA remains a practical first-line alternative. In the available network, blood component therapies did not emerge as consistently superior strategies compared with other hemostatic interventions. For 24-hour blood loss, APR was associated with lower blood loss than FFP, FC, and PCC. However, because the relevant comparisons were largely against active comparators rather than placebo or no hemostatic intervention, the efficacy of blood component therapies relative to no blood component therapy remains uncertain. Future large-scale RCTs are needed to further validate these findings.
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