Fibrin sealant- Grifols

Overview

Status: Recruiting
Keywords: Vascular surgery , hemostasis , fibrin sealant , stop bleeding , bypass graft , hemodialysis access graft , peripheral arterial disease
IRB Number: 00070635
Specialty: Nephrology and Hypertension, Vascular Surgery, Surgery, General
Sub Specialties: Dialysis,

Brief Summary

The purpose of this clinical trial is to obtain data to support licensure of a new human plasma-derived
FS (FS Grifols), manufactured by Instituto Grifols, S.A., Barcelona, Spain, by demonstrating that FS
Grifols is both safe and effective in achieving hemostasis during parenchymous tissue open surgeries.

 

Safety Objectives
Safety objectives include clinical safety, viral safety and immunogenicity.

 Efficacy Objectives
The efficacy objective is to evaluate the hemostatic efficacy of FS Grifols in parenchymous tissue
open surgeries.

Principal Investigator: Robin Kim
Department: General Surgery Faculty
Co Investigator: Daniel Kinikini
Co Investigator: Larry Kraiss
Co Investigator: Mark Sarfati

Contact Information

Name:Maria Maloney
Phone: 801-585-3663
Email: MARIA.MALONEY@HSC.UTAH.EDU

Inclusion Criteria

Subjects will be eligible for entry into the study once they meet all of the inclusion
criteria and none of the exclusion criteria:
1. Sign the written informed consent form (ICF). For pediatric patients, a
parent or legal guardian must sign ICF.
2. Are male or female.
3. No lower or upper age limit.
4. Must have hemoglobin (Hgb) ≥ 9.0 g/dL at Baseline (within 24 hours prior
to surgical procedure)1.
5. 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 TBS is identified on the cut raw liver surface (resection
area).
6. Intra-operative inclusion criteria: a TBS (as defined in section 7.1.3.1) can
be identified according to the investigator’s judgment, and

- The TBS has moderate bleeding according to the investigator’s
judgment.
- The intensity of the bleeding at the TBS will be rated by the
investigator using a pre-defined three-point scale

 

Exclusion Criteria

Subjects will be ineligible for entry into the study if they meet ANY of the following
exclusion criteria:
1. Require hepatic resection due to trauma.
2. Have an infection in the anatomic surgical area.
3. Have a history of severe (e.g. anaphylactic) reactions to blood or to any
blood-derived (human or animal) product.
4. Have previous known sensitivity to any FS Grifols component or any
Surgicel component.
5. (This exclusion criterion is removed).
6. Are unlikely to adhere to the protocol requirements, or to be cooperative
during the study conduct.
7. Are females who are pregnant or nursing a child at Baseline (within 24
hours prior to surgical procedure).1
8. Are receiving an organ transplant during the same surgical procedure.
9. Are undergoing another concurrent major surgical intervention beyond
the liver.
10. Are currently participating or have participated in another clinical study in

the context of which have received an investigational drug or device
within 3 months from the screening visit, or are scheduled to participate
during the course of this study.
11. Have undergone a therapeutic surgical procedure within 30 days from the
screening visit.
12. Were previously enrolled in clinical trials with FS Grifols.
13. Intra-operative exclusion criteria:
- A TBS cannot be identified
according to the investigator’s judgment.
- The TBS has a mild or severe bleeding according to the
investigator’s judgment.
- 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 the study treatment.
- Radiofrequency precoagulation of the liver resection surface,
except focal use of radiofrequency as primary haemostatic
treatment.
1 Laboratory testing for determination of subject’s eligibility (hemoglobin and
pregnancy testing, when applicable) will be performed locally at the investigative
site.