A Study of Fibrocaps in Liver Surgery in the Netherlands

A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.

This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.

The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. 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.

• Biological: Fibrocaps (fibrin sealant)
  human thrombin and fibrinogen topical powder
  Other Names:

  • PRO-0601
  • Fibrin Sealant
• Device: Gelatin sponge
  absorbable gelatin sponge for topical use
  Other Name: Spongostan

• Experimental: Fibrocaps + Gelatin sponge
  Topical Fibrocaps powder followed by application of gelatin sponge
  Interventions:

  • Biological: Fibrocaps (fibrin sealant)
  • Device: Gelatin sponge
• Active Comparator: Gelatin Sponge
  approved device for surgical bleeding
  Interventions:

  • Biological: Fibrocaps (fibrin sealant)
  • Device: Gelatin sponge

Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Subjects who are able and willing to provide written and signed informed consent
3. Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
4. Has a life expectancy of at least one year
5. Presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical

Exclusion Criteria:

1. Pregnant or lactating women
2. Has a known intolerance to blood products or to Fibrocaps components
3. Unwilling to receive human blood products
4. Subject has a known allergy to porcine gelatin
5. 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
6. Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery
7. 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
8. Platelets < 100 x109 PLT/L during screening
9. aPTT > 100 seconds during screening
10. INR > 2.5 during screening