Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery (BARRIER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by CryoLife, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01458561
First received: June 7, 2011
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

This is a prospective, multicenter, randomized, controlled investigation. Subjects in which bleeding from the exposed parenchymal surface is observed intraoperatively following the ligature of vessels visible with the unaided eye will be randomized to an adjunctive application of BioFoam or a standard topical hemostatic agent (Gelfoam with thrombin, in the form of Gelfoam Plus) to the entire exposed parenchymal surface. Following primary treatment of the exposed parenchymal surface as prescribed by the randomization scheme, treatment sites will be visually evaluated for the continued presence of bleeding. The overall objective of this investigation is to collect clinical data concerning the safety and effectiveness of BioFoam used as an adjunct to conservative measures of achieving hemostasis, such as manual pressure, cautery, and ligation, for intraoperative capillary, arteriolar, and venular bleeding (5 second stack of 5 gauze surface "Bleeding Score" = 1b or 2, score to be validated) on newly resected liver parenchyma in hemodynamically stable (American College of Surgeons' Advanced Trauma Life Support Class I Hemorrhage) and non-coagulopathic patients in the open treatment of exposed liver parenchyma versus a standard topical hemostatic agent, Gelfoam Plus. It is not intended for traumatic liver injury. The investigation will be conducted at a maximum of three investigational sites.


Condition Intervention Phase
Intraoperative Bleeding on Newly Resected Liver Parenchyma
Device: BioFoam Surgical Matrix
Device: Gelfoam Plus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Investigational Plan Evaluating the Operative Management of Parenchymal Bleeding By Means of an Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery

Resource links provided by NLM:


Further study details as provided by CryoLife, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 minutes following a single application of the prescribed hemostatic agent ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to hemostasis [ Time Frame: 1, 5, 7, and 10 minutes ] [ Designated as safety issue: No ]
  • Achievement of immediate hemostasis [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
  • Intraoperative blood loss [ Time Frame: Time from initial application to confirmed achievement of hemostasis (10 minutes following application of hemostatic agent) ] [ Designated as safety issue: Yes ]
  • Postoperative bilious drainage [ Time Frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Postoperative fluid loss [ Time Frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Duration of drainage [ Time Frame: Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Intraoperative blood product administration [ Time Frame: Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration) ] [ Designated as safety issue: Yes ]
  • Laboratory evaluations [ Time Frame: Preop (up to 30 days prior to surgery), intraoperative (2-3 hours from skin cut), immediately postop (up to 48 hours after final wound closure), up to 48 hrs prior to hospital discharge, 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yrs postop ] [ Designated as safety issue: Yes ]
  • Eval. for presence of device by MRI w/ & w/out contrast, & diagnose/eval. abdominal fluid collection/biliary leak, residual scarring, hepatic regeneration, & assess for emergence of primary/recurrent malignancy by MRI w/ or w/out contrast as appropriate [ Time Frame: Within 48 hours postoperatively, up to 48 hours prior to hospital discharge (avg. 5-7 days postop), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: Yes ]
  • Incidence of reoperation due to bleeding and/or biliary leakage [ Time Frame: After final wound closure through 2 year follow-up visit (average 2 yr duration) ] [ Designated as safety issue: Yes ]
  • Total time of operative procedure [ Time Frame: Skin cut to skin closure (average 4-5 hour duration) ] [ Designated as safety issue: Yes ]
  • Core body temperature [ Time Frame: At the time of test or control article application (expected average 3-4 hours from skin cut) ] [ Designated as safety issue: Yes ]
  • Total hospitalization time [ Time Frame: Hospital admission (day of surgery) until hospital discharge (average 5-7 days) ] [ Designated as safety issue: Yes ]
  • Additional hospitalization/surgical intervention [ Time Frame: Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration) ] [ Designated as safety issue: Yes ]
  • Evaluation of anti-BSA antibody titers [ Time Frame: Preop (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postop, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yrs postop ] [ Designated as safety issue: Yes ]
  • Incidence of procedure complications/adverse events [ Time Frame: Through final follow-up (2 years postoperatively) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BioFoam Surgical Matrix Device: BioFoam Surgical Matrix
A surgical adjunct in the open treatment of exposed liver parenchyma
Other Name: BioFoam
Active Comparator: Gelfoam Plus Device: Gelfoam Plus
A surgical adjunct in the open treatment of exposed liver parenchyma
Other Name: Gelfoam with thrombin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458561

Locations
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Marc L Melcher, MD, PhD    650-725-9891    melcherm@stanford.edu   
Principal Investigator: Marc L Melcher, MD, PhD         
Sub-Investigator: Waldo Concepcion, MD         
Sub-Investigator: Clark A Bonham, MD         
Sponsors and Collaborators
CryoLife, Inc.
Investigators
Study Director: Scott B Capps, MS CryoLife, Inc.
  More Information

No publications provided

Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT01458561     History of Changes
Other Study ID Numbers: BFM0801-C
Study First Received: June 7, 2011
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by CryoLife, Inc.:
Hemostatic agent
Liver surgery
Hemostasis

Additional relevant MeSH terms:
Blood Loss, Surgical
Hemorrhage
Intraoperative Complications
Pathologic Processes
Gelatin Sponge, Absorbable
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014