D Mirza 1 , A J W Millar , K Sharif , H Vilca-Melendez , M Rela , N Heaton Show Affiliations »
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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 . © Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities: Population
Interventions
Outcomes
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. © Georg Thieme Verlag KG Stuttgart · New York.
Entities: Chemical
Disease
Gene
Species
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Year: 2011
PMID： 21494994 DOI： 10.1055/s-0030-1267221
Source DB: PubMed Journal: Eur J Pediatr Surg ISSN： 0939-7248 Impact factor: 2.191