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Published on: May 23, 2025
The use of TachoSil in children undergoing liver resection with or without segmental liver transplantation
D Mirza1, A J W Millar, K Sharif
1Birmingham Children's Hospital, The Liver Unit, Birmingham, United Kingdom. darius.mirza@uhb.nhs.uk
Insights
TachoSil, a collagen patch, effectively controlled surgical bleeding in children undergoing liver resection. This study found TachoSil to be a safe and effective local hemostatic agent in pediatric patients.
Area of Science:
- Pediatric Surgery
- Hemostasis
- Biomaterials
Background:
- Local hemostatic agents are crucial for surgical bleeding control when standard methods fail.
- Limited research exists on the use of these agents in pediatric populations.
Purpose of the Study:
- To evaluate the safety and efficacy of TachoSil for hemostasis in children undergoing liver resection.
- To assess the time to hemostasis and adverse events associated with TachoSil use.
Main Methods:
- Prospective, open-label study involving 16 children (4 weeks to 6 years) undergoing liver resection.
- TachoSil applied for minor/moderate bleeding post-primary treatment; time to hemostasis was the primary endpoint.
- Safety assessed via adverse events, including infections and re-operations.
Main Results:
- Satisfactory hemostasis achieved in 81.3% of children within 3 minutes.
- No adverse events were attributed to TachoSil use.
- Observed adverse events were consistent with known complications of the underlying condition or surgical procedure.
Conclusions:
- TachoSil demonstrates safety and efficacy as a local hemostatic agent in pediatric liver surgery.
- The study supports the use of TachoSil for managing surgical hemorrhage in children.
Introduction:
Local haemostatic agents are used for the control of surgical haemorrhage when standard techniques are inadequate, but there are few studies of these products in children.
Patients And Methods:
This was a prospective, open-label study in which children (aged 4 weeks to 6 years) undergoing liver resection with or without segmental liver transplantation were treated with TachoSil, a collagen patch coated with a dry layer of human fibrinogen and human thrombin, if minor (i. e., oozing) or moderate bleeding was present after primary haemostatic treatment. Time to haemostasis after TachoSil application was the primary endpoint. Safety was assessed by adverse events (AEs), including post-operative infections, symptoms of graft rejection and re-operations.
Results:
Enrolment was stopped early after 16 children had entered the study. 13 children underwent whole liver resection and transplantation and 3 patients underwent segmental resection. Satisfactory haemostasis was achieved in 13 children (81.3%; 95% CI: 61.8-100%) at 3 min and in 1 child at 8 min. Occurrence of AEs was as expected, with most being known complications of the underlying disease, surgical procedure, or use of immunosuppressive medication. No AEs were considered to be related to the use of TachoSil.
Conclusions:
The use of TachoSil for haemostasis after primary haemostatic treatment appears to be safe and effective in children undergoing liver resection.
