Trial record 2 of 4 for:    profibrix

U.S. Study of Fibrocaps in Surgical Hemostasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ProFibrix, Inc.
ClinicalTrials.gov Identifier:
NCT01256164
First received: December 6, 2010
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.


Condition Intervention Phase
Postoperative Hemorrhage
Device: Fibrocaps (fibrin sealant)
Device: Gelfoam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A U.S. Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis

Resource links provided by NLM:


Further study details as provided by ProFibrix, Inc.:

Primary Outcome Measures:
  • Mean Time to Hemostasis (TTH) [ Time Frame: 0-10 minutes ] [ Designated as safety issue: No ]
    Time to hemostasis recorded from the first application of study treatment until cessation of bleeding


Secondary Outcome Measures:
  • Safety [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Number of participants with Adverse events and clinically-significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the TBS

  • Number of Subjects Achieving Hemostasis at 3 Minutes [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
  • Number of Participants Achieving Hemostasis at 5 Minutes [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Number of Patients Achieving Hemostasis at 10 Minutes [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrocaps + Gelfoam
After identification of a Target Bleeding Site (TBS), topical Fibrocaps should be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
Device: Fibrocaps (fibrin sealant)
Fibrocaps powder (max dose 1.5g) should be applied directly to the bleeding site or to the Gelfoam and then applied to the bleeding site. Re-application of 1.5 g of Fibrocaps is allowed.
Other Name: Pro-0601
Active Comparator: Gelfoam
Treatment is Gelfoam followed by manual pressure with sterile gauze. If hemostasis is not achieved within 10 minutes of the Start Time,the subject should be considered a treatment failure and the surgeon should implement additional hemostatic measures.
Device: Gelfoam
An identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.
Other Name: Gelfoam

Detailed Description:

This was a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 90 subjects undergoing spinal surgery, hepatic resection, specific soft tissue dissection, or peripheral vascular surgery, ((including peripheral artery bypass and arteriovenous graft formation for hemodialysis using either Polytetrafluoroethylene (PTFE) or native grafts)). Subjects were randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.

Use of the Fibrospray device was optional for spinal and vascular surgeries, but required for the general surgery procedures. All investigators using the Fibrospray device were trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female 18 years of age or older
  • Subjects who are able and willing to provide written and signed informed consent
  • All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
  • A life expectancy of at least one year

Intra-Operative inclusion criteria

  • Presence of mild or moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
  • Absence of intraoperative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
  • No intraoperative use of a topical hemostat containing thrombin
  • Approximate Target Bleeding Site surface area of no more than 100 square centimeters

Exclusion Criteria:

  • Pregnant or lactating women
  • Has a known intolerance to blood products or to Fibrocaps components
  • Unwilling to receive human blood products
  • Subject has a known allergy to porcine gelatin
  • Has a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
  • Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the 4 weeks after surgery
  • Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator
  • Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) 3 times (or more) the upper limit normal range during screening, except for subjects undergoing liver resection surgery where there is no upper limit for these analytes due to the nature of their disease.
  • Platelets < 10 x 10^9 /L during screening
  • Activated partial thromboplastin time (aPTT) > 100 seconds during screening
  • International normalized ratio (INR)greater than 2.5 during screening
  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: NCT01256164

Locations
United States, Indiana
Various sites
Indianapolis, Indiana, United States
Sponsors and Collaborators
ProFibrix, Inc.
Investigators
Study Director: Paul Frohna, MD, PhD ProFibrix, Inc.
  More Information

No publications provided

Responsible Party: ProFibrix, Inc.
ClinicalTrials.gov Identifier: NCT01256164     History of Changes
Other Study ID Numbers: FC-002
Study First Received: December 6, 2010
Results First Received: April 11, 2013
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ProFibrix, Inc.:
fibrin sealants
hemostatics
time to hemostasis

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Fibrin Tissue Adhesive
Gelatin Sponge, Absorbable
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014