PMID- 21494994 OWN - NLM STAT- MEDLINE DCOM- 20110816 LR - 20220331 IS - 1439-359X (Electronic) IS - 0939-7248 (Linking) VI - 21 IP - 2 DP - 2011 Mar TI - The use of TachoSil in children undergoing liver resection with or without segmental liver transplantation. PG - 111-5 LID - 10.1055/s-0030-1267221 [doi] AB - 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. CI - (c) Georg Thieme Verlag KG Stuttgart . New York. FAU - Mirza, D AU - Mirza D AD - Birmingham Children's Hospital, The Liver Unit, Birmingham, United Kingdom. darius.mirza@uhb.nhs.uk FAU - Millar, A J W AU - Millar AJ FAU - Sharif, K AU - Sharif K FAU - Vilca-Melendez, H AU - Vilca-Melendez H FAU - Rela, M AU - Rela M FAU - Heaton, N AU - Heaton N LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20110414 PL - United States TA - Eur J Pediatr Surg JT - European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie JID - 9105263 RN - 0 (Drug Combinations) RN - 0 (TachoSil) RN - 9001-32-5 (Fibrinogen) RN - EC 3.4.21.5 (Thrombin) SB - IM MH - Blood Loss, Surgical/*prevention & control MH - Child MH - Child, Preschool MH - Drug Combinations MH - Fibrinogen/*pharmacology MH - Follow-Up Studies MH - Hemostasis, Surgical/*instrumentation MH - Hepatectomy/*methods MH - Humans MH - Infant MH - Infant, Newborn MH - Liver Diseases/surgery MH - Liver Transplantation/*methods MH - Prospective Studies MH - Surgical Sponges MH - Thrombin/*pharmacology MH - Treatment Outcome EDAT- 2011/04/16 06:00 MHDA- 2011/08/17 06:00 CRDT- 2011/04/16 06:00 PHST- 2011/04/16 06:00 [entrez] PHST- 2011/04/16 06:00 [pubmed] PHST- 2011/08/17 06:00 [medline] AID - 10.1055/s-0030-1267221 [doi] PST - ppublish SO - Eur J Pediatr Surg. 2011 Mar;21(2):111-5. doi: 10.1055/s-0030-1267221. Epub 2011 Apr 14.