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Sponsor terminated due to signif. difficulty with pilot investigation enrollment
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioFoam Surgical Matrix | Experimental | Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct |
|
| Gelfoam Plus | Active Comparator | Control of bleeding using Gelfoam Plus as a surgical adjunct |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFoam Surgical Matrix | Device | Surgical adjunct to control bleeding in open liver surgery |
|
| 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 | Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent | 3 minutes following a single application of the prescribed hemostatic agent |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent |
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Preoperative Inclusion Criteria:
Preoperative Exclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Scott B Capps, MS | CryoLife, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94304 | United States | ||
| Swedish Medical Center |
All potential subjects were required to meet preoperative and operative screening criteria in order to be enrolled into the investigation and assigned to a treatment group.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | BioFoam Surgical Matrix | Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery |
| FG001 | Gelfoam Plus | Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BioFoam Surgical Matrix | Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery |
| BG001 | Gelfoam Plus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Study was terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | participants | 3 minutes following a single application of the prescribed hemostatic agent |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BioFoam Surgical Matrix | Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrence of Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Control subject, recurrence of hepatocellular carcinoma. Treatment of TACE with Cisplatin 12mg/Doxorubicin 12mg. Deemed as grade 2 (moderate) in severity, not related to either the study device or procedure. Event resolved with treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Hernia | Gastrointestinal disorders |
Early termination leading to small number of subjects evaluated (n=1).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott B. Capps, Vice President, Clinical Research | CryoLife, Inc. | 770-419-3355 | capps.scott@cryolife.com |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Gelfoam Plus | Device | Surgical adjunct in control of bleeding in open liver surgery |
|
|
| Achievement of Immediate Hemostasis | Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent | 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 from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent) |
| Amount of Postoperative Bilious Drainage | 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 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 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) | 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 | 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 | 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) | After final wound closure through 2 year follow-up visit (average 2 yr duration) |
| Total Time of Operative Procedure | Skin cut to skin closure (average 4-5 hour duration) |
| Core Body Temperature | 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) | 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 | 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 | 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 | Through final follow-up (2 years postoperatively) |
| Seattle |
| Washington |
| 98122 |
| United States |
Control of bleeding using Gelfoam Plus as a surgical adjunct
Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Control Bleeding in Gelfoam Plus Subjects/Participants |
Control of bleeding in subjects/participants who receive Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery |
|
|
| Secondary | 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. | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | minutes | 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent |
|
|
|
| Secondary | Achievement of Immediate Hemostasis | Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent | Study was terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | participants | 1 minute after application of prescribed hemostatic agent |
|
|
|
| Secondary | 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) | Study terminated before appropriate data collection/analysis | Posted | Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent) |
|
|
| Secondary | Amount of Postoperative Bilious Drainage | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | milliliters (mL) | Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively |
|
|
|
| Secondary | 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] | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | milliliters (mL) | Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively |
|
|
|
| Secondary | Duration of Drainage | Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | hours | Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively |
|
|
|
| Secondary | Amount of Intraoperative Blood Products Administered | Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure) | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | units of blood product(s) | Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration) |
|
|
|
| Secondary | Subject Laboratory Evaluations | Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | Number of participants with labs in rang | Preoperatively through final 2 year follow-up |
|
|
|
| Secondary | 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 | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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) | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | number of participants | After final wound closure through 2 year follow-up visit (average 2 yr duration) |
|
|
|
| Secondary | Total Time of Operative Procedure | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | minutes | Skin cut to skin closure (average 4-5 hour duration) |
|
|
|
| Secondary | Core Body Temperature | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | degrees Celcius | At the time of test or control article application (expected average 3-4 hours from skin cut) |
|
|
|
| Secondary | Total Hospitalization Time | Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days) | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | days | Hospital admission (day of surgery) until hospital discharge (average 5-7 days) |
|
|
|
| Secondary | Subjects Requiring Additional Hospitalization/Surgical Intervention | Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up | Study terminated before any subjects were enrolled into the BioFoam arm | Posted | Number | # of participants | Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration) |
|
|
|
| Secondary | 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 | Blood samples were to be analyzed in batches to more accurately assess for any changes over time; the study was terminated before the first batch was analyzed, so no data is available for anti-BSA titer testing. | Posted | 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 |
|
|
| Secondary | Number of Procedure Complications and/or Adverse Events | Posted | Number | Number of complications and AEs | Through final follow-up (2 years postoperatively) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Gelfoam Plus | Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery | 1 | 1 | 1 | 1 |
|
| Abnormal Monocyte Count | Surgical and medical procedures |
|
| Elevated AST | Surgical and medical procedures |
|
| Elevated Total Protein | Surgical and medical procedures |
|
| Hepatic Nodules | Hepatobiliary disorders |
|
| High ALT | Surgical and medical procedures |
|
| High Fibrinogen | Surgical and medical procedures |
|
| High GGTP | Surgical and medical procedures |
|
| High LDH | Surgical and medical procedures |
|
| High WBC | Surgical and medical procedures |
|
| Incisional Pain | Surgical and medical procedures |
|
| Intermittent Changes in Neutrophil Count (High) | Surgical and medical procedures |
|
| Liver Function Tests Elevated ALT & AST | Surgical and medical procedures |
|
| Low Bilirubin, Total | Surgical and medical procedures |
|
| Low Calcium | Surgical and medical procedures |
|
| Low Cholesterol | Surgical and medical procedures |
|
| Low Creatinine | Surgical and medical procedures |
|
| Low HGB | Surgical and medical procedures |
|
| Low Lipase | Surgical and medical procedures |
|
| Low Pancreatic Amylase | Surgical and medical procedures |
|
| Low Phosphorus | Surgical and medical procedures |
|
| Low Sodium | Surgical and medical procedures |
|
| Low WBC | Surgical and medical procedures |
|
| Lower Extremity Edema | General disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Sinusitis | Infections and infestations |
|
| Tachycardia | Cardiac disorders |
|
| Upper Respiratory Infection | Infections and infestations |
|
| Worsened Baseline Low HCT | Surgical and medical procedures |
|
| Worsened Baseline Low RBC | Surgical and medical procedures |
|
Authorship of 1st publication (Primary Paper) determined by Sponsor. If Primary Paper not sub. for publication within 18 months of study completion, Investigator may publish individual publication/presentation - proposal must be provided to Sponsor for review and comment at least 30 days prior to submission date/public disclosure. Sponsor to review within 30 days of receipt and can remove proprietary/confidential info and/or require delay in publication or public disclosure for up to 30 days.