Carolinas HealthCare System

Research and Clinical Trials

Title   Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostatis
Brief Description   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
Specialty/Disorder   Liver
Start Date   03/10/2014
IRB Number   1-14-165
Principal Investigator   Iannitti, David
For More Information, Contact   Jessica  Drummond , BSN
Phone:  (704) 446-4838  Fax:  (704) 446-4874 
Address:  1025 Morehead Medical Drive, Suite 6116
Charlotte, NC 28204
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