U.S. Study of Fibrocaps in Surgical Hemostasis

Postoperative Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256164
• Other study ID #: FC-002
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2010
• Last updated: June 6, 2014
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: ProFibrix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Postoperative Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	Various sites	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
ProFibrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Time to Hemostasis (TTH)	Time to hemostasis recorded from the first application of study treatment until cessation of bleeding	0-10 minutes	No
Secondary	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	28 Days	Yes
Secondary	Number of Subjects Achieving Hemostasis at 3 Minutes		3 minutes	No
Secondary	Number of Participants Achieving Hemostasis at 5 Minutes		5 minutes	No
Secondary	Number of Patients Achieving Hemostasis at 10 Minutes		10 minutes	No