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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

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

NCT ID

NCT01256164

First Posted

December 6, 2010

Last Updated

August 14, 2017

Sponsor

Mallinckrodt

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

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

Arm Title

Gelfoam

Arm Type

Active Comparator

Arm Description

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

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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