Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Instituto Grifols, S.A.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
A target bleeding site can be identified.
Target bleeding site is identified on the cut raw liver surface (resection area).
Target bleeding site has moderate bleeding according to the Investigator's judgment.
You may not be if
Require hepatic resection due to trauma.
Infection in the anatomic surgical area.
History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component.
Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
Receiving an organ transplant during the same surgical procedure.
Undergone a therapeutic surgical procedure within 30 days from the screening visit.
A target bleeding site cannot be identified.
The target bleeding site has a mild or severe bleeding.
Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.
Clareo Health | Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
