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U.S. Study of Fibrocaps in Surgical Hemostasis

Primary Purpose

Postoperative Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fibrocaps (fibrin sealant)
Gelfoam
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Hemorrhage focused on measuring fibrin sealants, hemostatics, time to hemostasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Various sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fibrocaps + Gelfoam

Gelfoam

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean Time to Hemostasis (TTH)
Time to hemostasis recorded from the first application of study treatment until cessation of bleeding

Secondary Outcome Measures

Safety
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
Number of Participants Achieving Hemostasis at 5 Minutes
Number of Patients Achieving Hemostasis at 10 Minutes

Full Information

First Posted
December 6, 2010
Last Updated
August 14, 2017
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT01256164
Brief Title
U.S. Study of Fibrocaps in Surgical Hemostasis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage
Keywords
fibrin sealants, hemostatics, time to hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrocaps + Gelfoam
Arm Type
Experimental
Arm Description
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.
Arm Title
Gelfoam
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fibrocaps (fibrin sealant)
Other Intervention Name(s)
Pro-0601
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Gelfoam
Intervention Description
An identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.
Primary Outcome Measure Information:
Title
Mean Time to Hemostasis (TTH)
Description
Time to hemostasis recorded from the first application of study treatment until cessation of bleeding
Time Frame
0-10 minutes
Secondary Outcome Measure Information:
Title
Safety
Description
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
Time Frame
28 Days
Title
Number of Subjects Achieving Hemostasis at 3 Minutes
Time Frame
3 minutes
Title
Number of Participants Achieving Hemostasis at 5 Minutes
Time Frame
5 minutes
Title
Number of Patients Achieving Hemostasis at 10 Minutes
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Frohna, MD, PhD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Various sites
City
Indianapolis
State/Province
Indiana
Country
United States

12. IPD Sharing Statement

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U.S. Study of Fibrocaps in Surgical Hemostasis

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