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

This study has been terminated.
(Sponsor terminated due to signif. difficulty with pilot investigation enrollment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01458561
First received: June 7, 2011
Last updated: April 29, 2015
Last verified: April 2015
  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
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:
  • Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent [ Time Frame: 3 minutes following a single application of the prescribed hemostatic agent ] [ Designated as safety issue: No ]
    Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent


Secondary Outcome Measures:
  • Time to Hemostasis [ Time Frame: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent ] [ Designated as safety issue: No ]
    Number of subjects achieving hemostasis [by assessing for hemostasis (yes/no)] at pre-determined time points: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent. Time to hemostasis is recorded as the first of the predetermined time points to receive a "yes" assessment.

  • Achievement of Immediate Hemostasis [ Time Frame: 1 minute after application of prescribed hemostatic agent ] [ Designated as safety issue: No ]
    Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent

  • Intraoperative Blood Loss [ Time Frame: Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent) ] [ Designated as safety issue: Yes ]
    Amount of blood lost between time of initial application of prescribed hemostatic agent and confirmed achievement of hemostasis (achievement of hemostasis eval. out to 10 minutes following application of prescribed hemostatic agent)

  • Amount of Postoperative Bilious Drainage [ Time Frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Amount of Postoperative Fluid Loss [ Time Frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively ] [ Designated as safety issue: Yes ]
    Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]

  • 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 ]
    Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively

  • Amount of Intraoperative Blood Products Administered [ Time Frame: Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration) ] [ Designated as safety issue: Yes ]
    Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)

  • Subject Laboratory Evaluations [ Time Frame: Preoperatively through final 2 year follow-up ] [ Designated as safety issue: Yes ]
    Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up

  • 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 postoperatively), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively ] [ Designated as safety issue: Yes ]
  • Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n) [ Time Frame: After final wound closure through 2 year follow-up visit (average 2 yr duration) ] [ Designated as safety issue: Yes ]
    Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)

  • 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 ]
    Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)

  • Subjects Requiring 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 ]
    Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up

  • Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers [ Time Frame: Preoperatively (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postoperatively, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yr postop ] [ Designated as safety issue: Yes ]
    Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points

  • Number of Procedure Complications and/or Adverse Events [ Time Frame: Through final follow-up (2 years postoperatively) ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BioFoam Surgical Matrix
Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
Device: BioFoam Surgical Matrix
Surgical adjunct to control bleeding in open liver surgery
Other Name: BioFoam
Active Comparator: Gelfoam Plus
Control of bleeding using Gelfoam Plus as a surgical adjunct
Device: Gelfoam Plus
Surgical adjunct in control of bleeding in open liver surgery
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 Model for End-Stage Liver Disease (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), blood urea nitrogen (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
Palo Alto, California, United States, 94304
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
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
Results First Received: July 5, 2013
Last Updated: April 29, 2015
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 May 21, 2015