Phase 3 Study of Fibrocaps™ in Surgical Bleeding (FINISH-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527357
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):

January 26, 2012
February 7, 2012
June 18, 2014
May 2012
April 2013   (Final data collection date for primary outcome measure)
Time to Hemostasis (TTH) [ Time Frame: Within 5 minutes of treatment ]
Same as current
Complete list of historical versions of study NCT01527357 on Archive Site
  • Incidence, severity and relationship of Adverse Events [ Time Frame: During 4 wks post-treatment ]
  • Incidence of Hemostasis [ Time Frame: 3 and 5 minutes post-treatment ]
Same as current
Not Provided
Not Provided
Phase 3 Study of Fibrocaps™ in Surgical Bleeding
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery.

This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial that will be conducted at clinical trial sites in the European Union and United States.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Mild or Moderate Surgical Bleeding
  • Biological: Fibrocaps (PRO-0601)
    Human fibrinogen and thrombin powder Single application during surgery
    Other Names:
    • PRO-0601
    • Fibrin sealant
  • Device: Gelatin sponge
    Single application during surgery
    Other Name: Gelfoam, Spongostan
  • Experimental: Fibrocaps (PRO-0601)
    Fibrocaps (PRO-0601) powder plus gelatin sponge
    • Biological: Fibrocaps (PRO-0601)
    • Device: Gelatin sponge
  • Active Comparator: Gelatin sponge
    Gelatin sponge (e.g., Gelfoam, Spongostan)
    Intervention: Device: Gelatin sponge

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
  2. Subject is undergoing one of the 4 surgical procedures described
  3. Subject age is >18 years at time of consent
  4. If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
  5. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
  6. Subject has not received blood transfusion between screening and study treatment
  7. Presence of mild to moderate surgical bleeding
  8. Absence of intra-operative complications
  9. No intra-operative use of a topical hemostat containing thrombin prior to study treatment
  10. Approximate bleeding site surface area of less than or equal to 100 cm2

Exclusion Criteria:

  1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
  2. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
  3. Subject has known allergy to porcine gelatin
  4. Subject is unwilling to receive blood products
  5. 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, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
  6. Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit for these analytes due to the nature of their disease
  7. Platelets < 100 x109 PLT/L during screening
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands,   United Kingdom,   United States
Not Provided
Not Provided
Not Provided
Study Director: Paul Frohna, MD, PhD Mallinckrodt
Principal Investigator: Robert J Porte, MD, PhD University Medical Center Groningen
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP