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

NCT02284256 | Completed Phase 3

• 2 other identifiers: FC-0052014-000816-32
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• Time to Hemostasis (TTH)

  Within 5 minutes of treatment

Study Arms (2)

Fibrocaps

EXPERIMENTAL

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

TachoSil

ACTIVE COMPARATOR

Human fibrinogen and thrombin powder. Single application during surgery

Drug: TachoSil

Interventions

Fibrocaps DRUG

Also known as: Raplixa

Fibrocaps

TachoSil DRUG

TachoSil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed an independent ethics committee (IEC)-approved informed consent document
• 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
• Subject age is \>18 years at time of consent
• If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
• 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
• 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
• Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
• Approximate TBS surface area of ≤ 100 cm\^2

You may not qualify if:

• Subject has known hypersensitivity to Fibrocaps or any of its components
• Subject has known allergy to porcine gelatin
• Subject has known hypersensitivity to Tachosil or any of the excipients included in Tachosil
• Subject is unwilling to receive blood products
• Subject is having hepatic surgery due to emergency-traumatic event
• 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
• 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)
• Subject has a platelet count \< 100 x10\^9 PLT/L during screening
• Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (15)

Universitaetsklinik Innsbruck

Innsbruck, A-6020, Austria

Location

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

Linz, A-4010, Austria

Location

Medizinische Universitaet Wien AKH

Vienna, A-1090, Austria

Location

Universitaetsklinikum Aachen, RWTH

Aachen, 52074, Germany

Location

Charite Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Krankenhaus Nordwest GmbH

Frankfurt am Main, D-60488, Germany

Location

J. W. Goethe Universitaetsklinik Frankfurt

Frankfurt am Main, D-60590, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsklinikum Leipzig AoeR

Leipzig, 04103, Germany

Location

Klinikum Rechts der Isar Munich

Munich, Germany

Location

Klinikum der LMU Muenchen - Campus Grosshadern

München, 81377, Germany

Location

Klinikum Stuttgart - Katharinenhospital (KH)

Stuttgart, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72976, Germany

Location

MeSH Terms

Interventions

Fibrin Tissue Adhesive; TachoSil

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Wolf Bechstein, MD

  J.W.Goethe-Universität

  PRINCIPAL INVESTIGATOR

• Martin Bodingbauer, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

AU (3); DE (12)