U.S. Study of Fibrocaps in Surgical Hemostasis

NCT01256164 | Completed Results

• 1 other identifier: FC-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Hemorrhage

Keywords

fibrin sealants; hemostatics; time to hemostasis

Outcome Measures

Primary Outcomes (1)

• Mean Time to Hemostasis (TTH)

  Time to hemostasis recorded from the first application of study treatment until cessation of bleeding

  0-10 minutes

Secondary Outcomes (4)

• Safety

  28 Days

• Number of Subjects Achieving Hemostasis at 3 Minutes

  3 minutes

• Number of Participants Achieving Hemostasis at 5 Minutes

  5 minutes

• Number of Patients Achieving Hemostasis at 10 Minutes

  10 minutes

Study Arms (2)

Fibrocaps + Gelfoam

EXPERIMENTAL

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)

Gelfoam

ACTIVE COMPARATOR

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

Interventions

Fibrocaps (fibrin sealant) DEVICE

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.

Also known as: Pro-0601

Fibrocaps + Gelfoam

Gelfoam DEVICE

An identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.

Gelfoam

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (1)

Various sites

Indianapolis, Indiana, United States

Location

Related Publications (1)

• Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

  PMID: 38695613 DERIVED

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Lawrence Hill
• Organization: Mallinckrodt

lawrence.hill@mallinckrodt.com

908-238-6370

Study Officials

• Paul Frohna, MD, PhD

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 13, 2017
• Results First Posted: November 11, 2013

Record last verified: 2017-08

Locations

US (1)