A Study of Fibrocaps in Liver Surgery in the Netherlands

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ProFibrix, Inc.
ClinicalTrials.gov Identifier:
NCT01256190
First received: December 6, 2010
Last updated: June 9, 2014
Last verified: June 2014

December 6, 2010
June 9, 2014
December 2010
September 2011   (final data collection date for primary outcome measure)
Time to Hemostasis [ Time Frame: 0-10 minutes ] [ Designated as safety issue: No ]
Time from application of treatment to cessation of bleeding
Same as current
Complete list of historical versions of study NCT01256190 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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 target bleeding site (TBS)
  • Incidence of Hemostasis at 5 Minutes [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Number of subjects in each group that achieved hemostasis at pre-specified times after treatment
  • Number of Subjects Achieving Hemostasis at 3 Minutes [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
  • Number of Patients Achieving Hemostasis at 10 Minutes [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Adverse events and clinically significant changes on laboratory or physical exam
Not Provided
Not Provided
 
A Study of Fibrocaps in Liver Surgery in the Netherlands
A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Postoperative Hemorrhage
  • 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
    Intervention: Device: Gelatin sponge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
October 2011
September 2011   (final data collection date for primary outcome measure)

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(PLT) < 100 x109 PLT/L during screening
  9. Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening
  10. International Normalized Ratio (INR) > 2.5 during screening
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01256190
FC-002 NL
Yes
ProFibrix, Inc.
ProFibrix, Inc.
Not Provided
Study Director: Paul Frohna, MD, PhD ProFibrix, Inc.
ProFibrix, Inc.
June 2014

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