U.S. Study of Fibrocaps in Surgical Hemostasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256164
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : November 11, 2013
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Hemorrhage Device: Fibrocaps (fibrin sealant) Device: Gelfoam Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Mean Time to Hemostasis (TTH) [ Time Frame: 0-10 minutes ]
    Time to hemostasis recorded from the first application of study treatment until cessation of bleeding

Secondary Outcome Measures :
  1. Safety [ Time Frame: 28 Days ]
    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

  2. Number of Subjects Achieving Hemostasis at 3 Minutes [ Time Frame: 3 minutes ]
  3. Number of Participants Achieving Hemostasis at 5 Minutes [ Time Frame: 5 minutes ]
  4. Number of Patients Achieving Hemostasis at 10 Minutes [ Time Frame: 10 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256164

United States, Indiana
Various sites
Indianapolis, Indiana, United States
Sponsors and Collaborators
Study Director: Paul Frohna, MD, PhD Mallinckrodt

Responsible Party: Mallinckrodt Identifier: NCT01256164     History of Changes
Other Study ID Numbers: FC-002
First Posted: December 8, 2010    Key Record Dates
Results First Posted: November 11, 2013
Last Update Posted: September 13, 2017
Last Verified: August 2017

Keywords provided by Mallinckrodt:
fibrin sealants
time to hemostasis

Additional relevant MeSH terms:
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Fibrin Tissue Adhesive
Gelatin Sponge, Absorbable