TerminatedNCT01458561BARRIERUpdated May 15, 2015Results posted

Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery

A Phase 3 interventional study of BioFoam Surgical Matrix and Gelfoam Plus in Intraoperative Bleeding, sponsored by CryoLife, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-15.

Sponsored by CryoLife, Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated

Sponsor terminated due to signif. difficulty with pilot investigation enrollment

Phase: Phase 3
Study type: Interventional
Enrollment: 1
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Intraoperative Bleeding

Browse trials for

Keywords

Hemostatic agent
Liver surgery
Hemostasis

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 1 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

CryoLife, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility 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)

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 1 participant (actual)

Study arms

Experimental
BioFoam Surgical Matrix
Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct
Device: BioFoam Surgical Matrix
Active comparator
Gelfoam Plus
Control of bleeding using Gelfoam Plus as a surgical adjunct
Device: Gelfoam Plus

Interventions

DeviceBioFoam Surgical Matrix
Surgical adjunct to control bleeding in open liver surgery
Also known as: BioFoam
DeviceGelfoam Plus
Surgical adjunct in control of bleeding in open liver surgery
Also known as: Gelfoam with thrombin

What researchers measure

Primary outcomes

Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent
Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent
Time frame: 3 minutes following a single application of the prescribed hemostatic agent

Secondary outcomes

Time to Hemostasis
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.
Time frame: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent
Achievement of Immediate Hemostasis
Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent
Time frame: 1 minute after application of prescribed hemostatic agent
Intraoperative Blood Loss
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)
Time frame: Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)
Amount of Postoperative Bilious Drainage
Time frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
Amount of Postoperative Fluid Loss
Amount of fluid lost postoperatively \[measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively\]
Time frame: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
Duration of Drainage
Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively
Time frame: Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively
Amount of Intraoperative Blood Products Administered
Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)
Time frame: Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)
Subject Laboratory Evaluations
Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up
Time frame: Preoperatively 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
Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)
Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)
Time frame: After final wound closure through 2 year follow-up visit (average 2 yr duration)
Total Time of Operative Procedure
Time frame: Skin cut to skin closure (average 4-5 hour duration)
Core Body Temperature
Time frame: At the time of test or control article application (expected average 3-4 hours from skin cut)
Total Hospitalization Time
Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)
Time frame: Hospital admission (day of surgery) until hospital discharge (average 5-7 days)
Subjects Requiring Additional Hospitalization/Surgical Intervention
Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up
Time frame: Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)
Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers
Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points
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
Number of Procedure Complications and/or Adverse Events
Time frame: Through final follow-up (2 years postoperatively)

Results

Posted May 15, 2015

Limitations and caveats

Early termination leading to small number of subjects evaluated (n=1).

Participant flow

Recruitment was limited to potential subjects who were being seen by a liver surgeon because they required a liver resection procedure. The first site was cleared to begin recruitment on October 20, 2010 and recruitment was closed on August 31, 2012 when all investigators were formally notified of the decision to terminate the study.

Participant flow — Overall Study
Milestone	BioFoam Surgical Matrix	Gelfoam Plus
Started	0	1
Completed	0	1
Not completed	0	0

Outcome measures

PrimaryTime to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent

Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent

Time frame:: 3 minutes following a single application of the prescribed hemostatic agent
Reported as:: Number · participants

Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent
participants	Control Bleeding in BioFoam Subjects/Participants	Control Bleeding in Gelfoam Plus Subjects/Participants
Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent	—	1

SecondaryTime to Hemostasis

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.

Time frame:: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent
Reported as:: Number · minutes

Time to Hemostasis
minutes	Subjects/Participants Receiving BioFoam	Subjects/Participants Receiving Gelfoam Plus
Time to Hemostasis	—	1

SecondaryAchievement of Immediate Hemostasis

Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent

Time frame:: 1 minute after application of prescribed hemostatic agent
Reported as:: Number · participants

Achievement of Immediate Hemostasis
participants	Achieve Immediate Hemostasis in BioFoam Subjects/Participants	Achievement of Immediate Hemostasis in Gelfoam Plus Subjects
Achievement of Immediate Hemostasis	—	1

SecondaryIntraoperative Blood Loss

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)

Time frame:: Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)

No measurements were reported for this outcome.

SecondaryAmount of Postoperative Bilious Drainage

Time frame:: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
Reported as:: Number · milliliters (mL)

Amount of Postoperative Bilious Drainage
milliliters (mL)	BioFoam Surgical Matrix	Gelfoam Plus
Amount of Postoperative Bilious Drainage	—	NA

SecondaryAmount of Postoperative Fluid Loss

Amount of fluid lost postoperatively \[measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively\]

Time frame:: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively
Reported as:: Number · milliliters (mL)

Amount of Postoperative Fluid Loss
milliliters (mL)	BioFoam Surgical Matrix	Gelfoam Plus
Amount of Postoperative Fluid Loss	—	NA

SecondaryDuration of Drainage

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

Time frame:: Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively
Reported as:: Number · hours

Duration of Drainage
hours	Duration of Postoperative Drainage in BioFoam Subjects	Duration of Postoperative Drainage in Gelfoam Plus Subjects
Duration of Drainage	—	NA

SecondaryAmount of Intraoperative Blood Products Administered

Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)

Time frame:: Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)
Reported as:: Number · units of blood product(s)

Amount of Intraoperative Blood Products Administered
units of blood product(s)	Amt. of Intraop. Blood Products Rec'd by BioFoam Subjects	Amt. of Intraop. Blood Products Rec'd by Gelfoam Plus Subjects
Amount of Intraoperative Blood Products Administered	—	NA

SecondarySubject Laboratory Evaluations

Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up

Time frame:: Preoperatively through final 2 year follow-up
Reported as:: Number · Number of participants with labs in rang

Subject Laboratory Evaluations
Number of participants with labs in rang	Laboratory Evaluations for BioFoam Subjects Out of Range	Laboratory Evaluations for Gelfoam Plus Subjects Out of Range
Subject Laboratory Evaluations	—	NA

SecondaryEval. 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
Reported as:: Number · participants

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
participants	Presence of Device Via MRI in BioFoam Surgical Matrix Subjects	Presence of Device Via MRI in Gelfoam Plus Subjects
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	—	1

SecondaryNumber of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)

Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)

Time frame:: After final wound closure through 2 year follow-up visit (average 2 yr duration)
Reported as:: Number · number of participants

Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)
number of participants	BioFoam Subj. Requiring Reop. Due to Bleeding/Biliary Leakage	Gelfoam Plus Subj. Requiring Reop. Due to Bleeding/Bili. Leak
Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)	—	0

SecondaryTotal Time of Operative Procedure

Time frame:: Skin cut to skin closure (average 4-5 hour duration)
Reported as:: Number · minutes

Total Time of Operative Procedure
minutes	Total Time of Procedure for BioFoam Surgical Matrix Subjects	Total Time of Procedure for Gelfoam Plus Subjects
Total Time of Operative Procedure	—	300

SecondaryCore Body Temperature

Time frame:: At the time of test or control article application (expected average 3-4 hours from skin cut)
Reported as:: Number · degrees Celcius

Core Body Temperature
degrees Celcius	Core Body Temp of BioFoam Subjects During Hemostat Application	Core Body Temp of Gelfoam Plus During Hemostat Application
Core Body Temperature	—	36.5

SecondaryTotal Hospitalization Time

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

Time frame:: Hospital admission (day of surgery) until hospital discharge (average 5-7 days)
Reported as:: Number · days

Total Hospitalization Time
days	Length of Hospital Stay for BioFoam Surgical Matrix Subjects	Length of Hospital Stay for Gelfoam Plus Subjects
Total Hospitalization Time	—	NA

SecondarySubjects Requiring Additional Hospitalization/Surgical Intervention

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

Time frame:: Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)
Reported as:: Number · # of participants

Subjects Requiring Additional Hospitalization/Surgical Intervention
# of participants	# of BioFoam Subjects Requiring Hospitalization/Intervention	# of Gelfoam Plus Subj. Requiring Hospitalization/Intervention
Subjects Requiring Additional Hospitalization/Surgical Intervention	—	NA

SecondaryEvaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers

Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points

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

No measurements were reported for this outcome.

SecondaryNumber of Procedure Complications and/or Adverse Events

Time frame:: Through final follow-up (2 years postoperatively)
Reported as:: Number · Number of complications and AEs

Number of Procedure Complications and/or Adverse Events
Number of complications and AEs	Complications/Adverse Events in Subjects Receiving BioFoam	Complications/Adverse Events in Subj. Receiving Gelfoam Plus
Number of Procedure Complications and/or Adverse Events	—	31

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BioFoam Surgical Matrix	—	—	—
Gelfoam Plus	—	1/1 (100%)	1/1 (100%)

Most frequent serious events

Most frequent serious events
Event	BioFoam Surgical Matrix	Gelfoam Plus
Recurrence of Hepatocellular CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	—	1/1

Most frequent other events

Showing 10 of 30

Most frequent other events
Event	BioFoam Surgical Matrix	Gelfoam Plus
Abdominal HerniaGastrointestinal disorders	—	1/1
Abnormal Monocyte CountSurgical and medical procedures	—	1/1
Elevated ASTSurgical and medical procedures	—	1/1
Elevated Total ProteinSurgical and medical procedures	—	1/1
Hepatic NodulesHepatobiliary disorders	—	1/1
High ALTSurgical and medical procedures	—	1/1
High FibrinogenSurgical and medical procedures	—	1/1
High GGTPSurgical and medical procedures	—	1/1
High LDHSurgical and medical procedures	—	1/1
High WBCSurgical and medical procedures	—	1/1

Baseline characteristics

Age, Categorical
Age, Categorical(participants)	BioFoam Surgical Matrix	Gelfoam Plus	Total
<=18 years	—	0	0
Between 18 and 65 years	—	1	1
>=65 years	—	0	0

Age, Continuous
Age, Continuous(years)	BioFoam Surgical Matrix	Gelfoam Plus	Total
Mean	—	57 ± 0	57 ± 0

Gender
Gender(participants)	BioFoam Surgical Matrix	Gelfoam Plus	Total
Female	—	0	0
Male	—	1	1

Region of Enrollment
Region of Enrollment(participants)	BioFoam Surgical Matrix	Gelfoam Plus	Total
United States	—	1	1

Study locations

2 sites

Stanford University Medical Center
Palo Alto, California 94304, United States
Swedish Medical Center
Seattle, Washington 98122, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01458561
Lead sponsor: CryoLife, Inc.
Collaborators: United States Department of Defense
Responsible party: Sponsor
First posted: Oct 25, 2011
Start date: Oct 2010
Primary completion: Sep 2012
Completion: Sep 2012
Results posted: May 15, 2015
Last update: May 15, 2015

Study contacts

Scott B Capps, MS

study director · CryoLife, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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