Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery

NCT01458561 | Terminated Phase 3 Results DMC

• 1 other identifier: BFM0801-C
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief 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

Intraoperative Bleeding

Keywords

Hemostatic agent; Liver surgery; Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Time to Hemostasis

  1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent

• Achievement of Immediate Hemostasis

  1 minute after application of prescribed hemostatic agent

• Intraoperative Blood Loss

  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

  Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively

Study Arms (2)

BioFoam Surgical Matrix

EXPERIMENTAL

Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct

Device: BioFoam Surgical Matrix

Gelfoam Plus

ACTIVE COMPARATOR

Control of bleeding using Gelfoam Plus as a surgical adjunct

Device: Gelfoam Plus

Interventions

BioFoam Surgical Matrix DEVICE

Surgical adjunct to control bleeding in open liver surgery

Also known as: BioFoam

BioFoam Surgical Matrix

Gelfoam Plus DEVICE

Surgical adjunct in control of bleeding in open liver surgery

Also known as: Gelfoam with thrombin

Gelfoam Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CryoLife, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (2)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

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

Results Point of Contact

• Title: Scott B. Capps, Vice President, Clinical Research
• Organization: CryoLife, Inc.

capps.scott@cryolife.com

770-419-3355

Study Officials

• Scott B Capps, MS

  CryoLife, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 15, 2015
• Results First Posted: May 15, 2015

Record last verified: 2015-04

Locations

US (2)