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A Study of Fibrocaps in Liver Surgery in the Netherlands

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256190
First Posted: December 8, 2010
Last Update Posted: August 22, 2016
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.
Information provided by (Responsible Party):
Mallinckrodt
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Mallinckrodt:

Primary Outcome Measures:
  • Time to Hemostasis [ Time Frame: 0-10 minutes ]
    Time from application of treatment to cessation of bleeding


Secondary Outcome Measures:
  • Safety [ Time Frame: 28 days ]
    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 ]
    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 ]
  • Number of Patients Achieving Hemostasis at 10 Minutes [ Time Frame: 10 minutes ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256190


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

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01256190     History of Changes
Other Study ID Numbers: FC-002 NL
First Submitted: December 6, 2010
First Posted: December 8, 2010
Results First Submitted: April 11, 2013
Results First Posted: May 15, 2014
Last Update Posted: August 22, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Fibrin Tissue Adhesive
Hemostatics
Coagulants