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
  Purpose

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.


Condition Intervention Phase
Postoperative Hemorrhage
Biological: Fibrocaps (fibrin sealant)
Device: Gelatin sponge
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ProFibrix, Inc.:

Primary Outcome Measures:
  • Time to Hemostasis [ Time Frame: 0-10 minutes ] [ Designated as safety issue: No ]
    Time from application of treatment to cessation of bleeding


Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrocaps + Gelatin sponge
Topical Fibrocaps powder followed by application of gelatin sponge
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
Active Comparator: Gelatin Sponge
approved device for surgical bleeding
Device: Gelatin sponge
absorbable gelatin sponge for topical use
Other Name: Spongostan

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256190

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
ProFibrix, Inc.
Investigators
Study Director: Paul Frohna, MD, PhD ProFibrix, Inc.
  More Information

No publications provided

Responsible Party: ProFibrix, Inc.
ClinicalTrials.gov Identifier: NCT01256190     History of Changes
Other Study ID Numbers: FC-002 NL
Study First Received: December 6, 2010
Results First Received: April 11, 2013
Last Updated: June 9, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014