Clincosm LogoSign in Get a demo

A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery

Sponsor
Mallinckrodt (Industry)
Overall Status
Completed
CT.gov ID
NCT02284256
Collaborator
(none)
150
Enrollment
15
Locations
2
Arms
9
Duration (Months)
10
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical FibrocapsTM (RaplixaTM) and Tachosil® in Surgical Hemostasis During Hepatic Resection
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fibrocaps

Human fibrinogen and thrombin powder. Single application during surgery Other Names: Raplixa PRO-0601 Fibrin sealant Device: Gelatin sponge. Single application during surgery Other Name: Spongostan

Drug: Fibrocaps
Other Names:
  • Raplixa

    		•
    Active Comparator: TachoSil

    Human fibrinogen and thrombin powder. Single application during surgery

    Drug: TachoSil

    Outcome Measures

    Primary Outcome Measures

    1. Time to Hemostasis (TTH) [Within 5 minutes of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria (pre-surgery):

    1. Subject has signed an independent ethics committee (IEC)-approved informed consent document

    2. Subject is undergoing hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines

    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

    Inclusion Criteria (during surgery):

    1. Presence of mild to moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical

    2. Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety

    3. Approximate TBS surface area of ≤ 100 cm^2

    Exclusion Criteria:

    1. Subject has known hypersensitivity to Fibrocaps or any of its components

    2. Subject has known allergy to porcine gelatin

    3. Subject has known hypersensitivity to Tachosil or any of the excipients included in Tachosil

    4. Subject is unwilling to receive blood products

    5. Subject is having hepatic surgery due to emergency-traumatic event

    6. Subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections

    7. Subject 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 international normalized ratio (INR) > 2.5 or activated partial thromboplastin time (aPTT) > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)

    8. Subject has a platelet count < 100 x10^9 PLT/L during screening

    9. Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures

    10. Subject is 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 within 6 weeks after surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitaetsklinik Innsbruck Innsbruck Austria A-6020
    2 Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. Linz Austria A-4010
    3 Medizinische Universitaet Wien AKH Wien Austria A-1090
    4 Universitaetsklinikum Aachen, RWTH Aachen Germany 52074
    5 Charite Campus Virchow-Klinikum Berlin Germany 13353
    6 Krankenhaus Nordwest GmbH Frankfurt am Main Germany D-60488
    7 J. W. Goethe Universitaetsklinik Frankfurt Frankfurt am Main Germany D-60590
    8 Universitaetsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    9 Medizinische Hochschule Hannover Hanover Germany 30625
    10 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    11 Universitaetsklinikum Leipzig AoeR Leipzig Germany 04103
    12 Klinikum der LMU Muenchen - Campus Grosshadern Muenchen Germany 81377
    13 Klinikum Rechts der Isar Munich Munich Germany
    14 Klinikum Stuttgart - Katharinenhospital (KH) Stuttgart Germany
    15 Universitaetsklinikum Tuebingen Tuebingen Germany 72976

    Sponsors and Collaborators

    • Mallinckrodt

    Investigators

    • Principal Investigator: Wolf Bechstein, MD, J.W.Goethe-Universität
    • Principal Investigator: Martin Bodingbauer, MD, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mallinckrodt
    ClinicalTrials.gov Identifier:
    NCT02284256
    Other Study ID Numbers:
    • FC-005
    • 2014-000816-32
    First Posted:
    Nov 5, 2014
    Last Update Posted:
    Aug 16, 2017
    Last Verified:
    Aug 1, 2017

    Study Results

    No Results Posted as of Aug 16, 2017