Clinical trial NCT02284256: A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Bleeding
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to Hemostasis (TTH)
timeFrame: Within 5 minutes of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitaetsklinik Innsbruck
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
city: Wien
country: Austria
facility: Medizinische Universitaet Wien AKH
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen, RWTH
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest GmbH
city: Frankfurt am Main
country: Germany
facility: J. W. Goethe Universitaetsklinik Frankfurt
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AoeR
city: Muenchen
country: Germany
facility: Klinikum der LMU Muenchen - Campus Grosshadern
city: Munich
country: Germany
facility: Klinikum Rechts der Isar Munich
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart - Katharinenhospital (KH)
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
Study officials:
affiliation: J.W.Goethe-Universität
name: Wolf Bechstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Martin Bodingbauer, MD
role: PRINCIPAL_INVESTIGATOR
References: