Patient & Visitor Alert: Because flu cases are on the rise, starting February 24, children 12 and younger will be restricted from visiting hospitals and certain inpatient facilities throughout Carolinas HealthCare System. Learn more.
Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostatis
A research study of a new fibrin sealant, product named FS Grifols used during scheduled liver surgery. This product will be applied during liver surgery to liver tissue with moderate (gradual and steady) bleeding with the purpose of learning about its safety and efficacy in reducing time to haemostatis (cessation of bleeding) as compared to Surgicel(R) (an approved product to make the blood clot and shorten the bleeding time).
Who may be Eligible
1. Sign written informed consent, (2) no age limit, (3) must have hemoglobin (Hgb) >9.0 g/dL at baseline (within 24 hours of surgical procedure, 4. Require an elective (non-emergency), open (non-laparoscopic) hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume) where target bleeding site (TBS) is identified on the cut raw liver surface (resection area), 5. Intra-operative inclusion criteria: a TBS can be identified according to the investigator's judgement and the TBS has moderate bleeding according to the investigator's judgement, the intensity of the bleeding at the TBS will be rated by the investigator using a pre-defined three-point scale