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

NCT ID: NCT02284256

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

Surgical Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Fibrocaps

Intervention Type: DRUG

TachoSil

Human fibrinogen and thrombin powder. Single application during surgery

Group Type: ACTIVE_COMPARATOR

TachoSil

Intervention Type: DRUG

Interventions

Fibrocaps

Intervention Type: DRUG

TachoSil

Intervention Type: DRUG

Other Intervention Names

Raplixa

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolf Bechstein, MD

Role: PRINCIPAL_INVESTIGATOR

J.W.Goethe-Universität

Martin Bodingbauer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Universitaetsklinik Innsbruck

Innsbruck, , Austria

Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

Linz, , Austria

Medizinische Universitaet Wien AKH

Vienna, , Austria

Universitaetsklinikum Aachen, RWTH

Aachen, , Germany

Charite Campus Virchow-Klinikum

Berlin, , Germany

Krankenhaus Nordwest GmbH

Frankfurt am Main, , Germany

J. W. Goethe Universitaetsklinik Frankfurt

Frankfurt am Main, , Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitaetsklinikum Leipzig AoeR

Leipzig, , Germany

Klinikum Rechts der Isar Munich

Munich, , Germany

Klinikum der LMU Muenchen - Campus Grosshadern

München, , Germany

Klinikum Stuttgart - Katharinenhospital (KH)

Stuttgart, , Germany

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Countries

Austria; Germany

Other Identifiers

2014-000816-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FC-005

Identifier Type: -

Identifier Source: org_study_id