U.S. Study of Fibrocaps in Surgical Hemostasis

• Safety [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
  Adverse events and clinically-significant changes/findings on labs and physical examination
• Proportion of subjects achieving hemostasis within each group at 3, 5, and 10 minutes. [ Time Frame: 3, 5, and 10 minutes ] [ Designated as safety issue: No ]

The purpose of this study is to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.

This will be 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 PTFE or native grafts). Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.

Use of the Fibrospray device is optional for spinal and vascular surgeries, but required for the general surgery procedures. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.

• Device: Fibrocaps (fibrin sealant)
  Fibrocaps powder (max dose 1.5g) is 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
• Device: Gelfoam
  An identified Target Bleeding Site (TBS) will be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.
  Other Name: Gelfoam

• Experimental: Fibrocaps + Gelfoam
  After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will 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.
  Intervention: Device: Fibrocaps (fibrin sealant)
• Active Comparator: Gelfoam
  Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
  Intervention: Device: Gelfoam

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 procine 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