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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284256
First Posted: November 5, 2014
Last Update Posted: August 16, 2017
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
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 Intervention Phase
Surgical Bleeding Drug: Fibrocaps Drug: TachoSil Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Time to Hemostasis (TTH) [ Time Frame: Within 5 minutes of treatment ]

Enrollment: 150
Study Start Date: November 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Raplixa
Active Comparator: TachoSil
Human fibrinogen and thrombin powder. Single application during surgery
Drug: TachoSil

  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 (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):

  6. 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
  7. Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
  8. 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
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): NCT02284256


Locations
Austria
Universitaetsklinik Innsbruck
Innsbruck, Austria, A-6020
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz, Austria, A-4010
Medizinische Universitaet Wien AKH
Wien, Austria, A-1090
Germany
Universitaetsklinikum Aachen, RWTH
Aachen, Germany, 52074
Charite Campus Virchow-Klinikum
Berlin, Germany, 13353
Krankenhaus Nordwest GmbH
Frankfurt am Main, Germany, D-60488
J. W. Goethe Universitaetsklinik Frankfurt
Frankfurt am Main, Germany, D-60590
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitaetsklinikum Leipzig AoeR
Leipzig, Germany, 04103
Klinikum der LMU Muenchen - Campus Grosshadern
Muenchen, Germany, 81377
Klinikum Rechts der Isar Munich
Munich, Germany
Klinikum Stuttgart - Katharinenhospital (KH)
Stuttgart, Germany
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
  More Information

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02284256     History of Changes
Other Study ID Numbers: FC-005
2014-000816-32 ( EudraCT Number )
First Submitted: November 3, 2014
First Posted: November 5, 2014
Last Update Posted: August 16, 2017
Last Verified: August 2017