TY - JOUR
T1 - A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy
T2 - anatomic versus non-anatomic resection
AU - Koea, Jonathan B.
AU - Batiller, Jonathan
AU - Aguirre, Nicolas
AU - Shen, Jessica
AU - Kocharian, Richard
AU - Bochicchio, Grant
AU - Garden, O. James
N1 - Funding Information:
The protocol, consent and patient information documents were submitted by each investigator to the appropriate local Ethics Committee or Institutional Review Board and approval obtained. The study was conducted in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (1996), the US Food and Drug Administration (FDA) regulations (Title 21 Code of Federal Regulations [CFR] Parts 50, 54, 56 and 312), the Declaration of Helsinki (2008), the European Union Trial Directive (2011/20/EC, May 2001) and the EU GCP Directive (2005/28/EC). An independent Data Safety Monitoring Board (DSMB) was established and reviewed all data for any safety issues if a prospectively defined stopping criteria was met. A Clinical Events Committee (CEC) was created to adjudicate adverse events that were considered as potentially related to the TBS bleeding or were considered thrombotic events. Membership of these boards was independent with no affiliation to the trial sponsor.
Publisher Copyright:
© 2016 International Hepato-Pancreato-Biliary Association Inc.
PY - 2016
Y1 - 2016
N2 - 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 (1:1) 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.
AB - 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 (1:1) 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.
UR - http://www.scopus.com/inward/record.url?scp=84976388558&partnerID=8YFLogxK
U2 - 10.1016/j.hpb.2015.12.006
DO - 10.1016/j.hpb.2015.12.006
M3 - Article
C2 - 27017161
AN - SCOPUS:84976388558
SN - 1365-182X
VL - 18
SP - 221
EP - 228
JO - HPB
JF - HPB
IS - 3
ER -