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An Investigational Plan Evaluating the Operative Management of Parenchymal Bleeding By Means of an Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Intraoperative Bleeding on Newly Resected Liver Parenchyma

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Trial Information

An Investigational Plan Evaluating the Operative Management of Parenchymal Bleeding By Means of an Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery


Preoperative

Inclusion Criteria:



- Subject is undergoing an elective liver resection procedure that requires treatment
of the exposed parenchymal surface due to the intraoperative presence of blood
following ligature of vessels visible with the unaided eye;

- Subject has adequate hepatic function as indicated by a MELD score of <10 at ≤30 days
and at ≤7 days prior to surgery;

- Subject has adequate hemostatic function identified as an international normalized
ratio (INR), platelet count, and activated clotting time within the central
laboratory's normal reference range;

- Subject or an authorized legal representative is willing and able to give prior
written informed consent for investigation participation; and

- Subject is ≥ 18 years of age.

Preoperative Exclusion Criteria:

- Subject with known or suspected sensitivity to products of bovine origin

- Subject with known or suspected sensitivity to glutaraldehyde

- Subject with active infection (either systemic or in the treatment region) or hepatic
cysts due to parasitic disease and/or abscesses due to bacterial and/or amebic
disease;

- Subject with abnormal calcium metabolism identified as values for ionized calcium and
serum calcium corrected for serum albumin that are outside of the central
laboratory's normal reference range;

- Subject with abnormal renal status identified as an estimated glomerular filtration
rate (eGFR), BUN, serum creatinine, sodium, chloride, potassium, and/or bicarbonate
values that are outside of the central laboratory's normal reference range;

- Subject with hyperparathyroidism identified as an intact parathyroid hormone level
>72 pg/mL, serum calcium >10.6 mg/dL, and phosphate <2.4 mg/dL, and, for secondary or
tertiary hyperparathyroidism only, alkaline phosphatase >147 U/L

- Subject with a pancreatic amylase and/or lipase value outside of the central
laboratory's normal reference range;

- Subject with blunt and/or penetrating liver trauma;

- Subject diagnosed with any coagulation disorder;

- Subject whose life-expectancy is less than that required for the prescribed follow-up
duration;

- Subject who has been treated with an investigational product and has not completed
the entire follow-up period for that investigational product;

- Subject with any surgical implant that would interfere with necessary follow-up
imaging;

- Subject who is pregnant (as confirmed by a urine pregnancy test), planning on
becoming pregnant during the follow-up period, or actively breast-feeding;

- Subject who is undergoing concomitant procedures other than (1)cholecystectomy, (2)
umbilical hernia repair, or (3) uncomplicated colon resection (i.e., no significant
spillage);

- Subject who is immunocompromised;

- Subject with an American Society of Anesthesiologist (ASA) Score >2

- Subject with a MELD score of ≥10 at ≤30 days or at ≤7 days prior to surgery;

- Subject diagnosed with an autoimmune disease; and

- Subject in whom the surgeon intends to use adhesion prevention products.

- Subject who is returning to the operating room (OR) to address a complication
associated with a liver resection, including but not limited to hematoma evacuation
and biliary leak.

Intraoperative Inclusion Criterion:

- Subject in whom bleeding (assignment of a "Bleeding Score" of 1 or 2) from the exposed
parenchymal surface after ligature of vessels visible with the unaided eye and removal of
any clamps used for hemostasis is observed

Intraoperative Exclusion Criterion:

- Subject in whom any major intraoperative bleeding incidences during the resection
procedure occurred (i.e., subject with assignment of an American College of Surgeons
Advanced Trauma Life Support Hemorrhage Class of II, III, or IV Hemorrhage)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Demonstrate a decrease in the time to achieve intraoperative hemostasis following open liver resection surgery in subjects receiving an application of BioFoam compared to a standard topical hemostatic agent.

Outcome Time Frame:

3 minutes following a single application of the prescribed hemostatic agent

Safety Issue:

No

Principal Investigator

Scott B Capps, MS

Investigator Role:

Study Director

Investigator Affiliation:

CryoLife, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

BFM0801-C

NCT ID:

NCT01458561

Start Date:

October 2010

Completion Date:

September 2014

Related Keywords:

  • Intraoperative Bleeding on Newly Resected Liver Parenchyma
  • Hemostatic agent
  • Liver surgery
  • Hemostasis
  • Hemorrhage
  • Blood Loss, Surgical

Name

Location

Stanford University Medical CenterStanford, California  94305-5408