- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458561
Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery (BARRIER)
An Investigational Plan Evaluating the Operative Management of Parenchymal Bleeding By Means of an Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
California
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Palo Alto, California, United States, 94304
- Stanford University Medical Center
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Washington
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Seattle, Washington, United States, 98122
- Swedish Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BioFoam Surgical Matrix
Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
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Surgical adjunct to control bleeding in open liver surgery
Other Names:
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ACTIVE_COMPARATOR: Gelfoam Plus
Control of bleeding using Gelfoam Plus as a surgical adjunct
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Surgical adjunct in control of bleeding in open liver surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent
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3 minutes following a single application of the prescribed hemostatic agent
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Hemostasis
Time Frame: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent
|
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.
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1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent
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Achievement of Immediate Hemostasis
Time Frame: 1 minute after application of prescribed hemostatic agent
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Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent
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1 minute after application of prescribed hemostatic agent
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Intraoperative Blood Loss
Time Frame: Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)
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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)
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Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)
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Amount of Postoperative Bilious Drainage
Time Frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
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Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
|
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Amount of Postoperative Fluid Loss
Time Frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
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Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]
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Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
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Duration of Drainage
Time Frame: Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively
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Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively
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Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively
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Amount of Intraoperative Blood Products Administered
Time Frame: Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)
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Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)
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Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)
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Subject Laboratory Evaluations
Time Frame: Preoperatively through final 2 year follow-up
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Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up
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Preoperatively through final 2 year follow-up
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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
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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
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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)
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Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required?
y/n)
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After final wound closure through 2 year follow-up visit (average 2 yr duration)
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Total Time of Operative Procedure
Time Frame: Skin cut to skin closure (average 4-5 hour duration)
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Skin cut to skin closure (average 4-5 hour duration)
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Core Body Temperature
Time Frame: At the time of test or control article application (expected average 3-4 hours from skin cut)
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At the time of test or control article application (expected average 3-4 hours from skin cut)
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Total Hospitalization Time
Time Frame: Hospital admission (day of surgery) until hospital discharge (average 5-7 days)
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Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)
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Hospital admission (day of surgery) until hospital discharge (average 5-7 days)
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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)
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Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up
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Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)
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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
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Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points
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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
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Number of Procedure Complications and/or Adverse Events
Time Frame: Through final follow-up (2 years postoperatively)
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Through final follow-up (2 years postoperatively)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BFM0801-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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