A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection.
HPB (Oxford)
; 18(3): 221-8, 2016 Mar.
Article
em En
| MEDLINE
| ID: mdl-27017161
ABSTRACT
BACKGROUND:
This multicentre, randomized clinical trial assessed the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch (FP) in treating parenchymal bleeding following anatomic and non-anatomic liver resections.METHODS:
One hundred and two patients were stratified according to the type of hepatic resection (anatomic/non-anatomic), and randomized (11) after identification of an appropriate bleeding site, to FP vs Standard of Care (SoC, manual compression ± topical haemostat). The primary endpoint was haemostasis at 4 min from bleeding site identification with no re-bleeding requiring re-treatment.RESULTS:
The FP was superior in achieving haemostasis at 4 min (96%, 48/50) to SoC (46%, 24/52; p < 0.001). Stratification for resection type showed treatment differences for primary endpoint for anatomic (24/25 FP vs 13/23 SoC; p = 0.001) and non-anatomic liver resections (24/25FP vs 11/29 SoC; p < 0.001). Adverse events related to the study procedure were reported in 40/50 patients (80%) in the FP group and 43/52 patients (83%) in the SoC group. One (2%) adverse event (infected intra-abdominal fluid collection) was possibly related to study treatment.CONCLUSION:
This clinical trial confirms that the FP is safe and highly effective in controlling parenchymal bleeding following hepatectomy regardless of the type of resection. ClinicalTrials.gov NCT01993888.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Adesivos Teciduais
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Hemostáticos
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Adesivo Tecidual de Fibrina
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Técnicas Hemostáticas
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Hemorragia Pós-Operatória
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Hepatectomia
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Guideline
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Observational_studies
/
Prognostic_studies
Limite:
Adult
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Aged
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Aged80
/
Female
/
Humans
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Male
/
Middle aged
País/Região como assunto:
America do norte
/
Europa
/
Oceania
Idioma:
En
Revista:
HPB (Oxford)
Assunto da revista:
GASTROENTEROLOGIA
Ano de publicação:
2016
Tipo de documento:
Article