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

Phase 3

Completed

• Conditions: Surgical Bleeding
• Interventions: Drug: Fibrocaps; Drug: TachoSil

• Registration Number: NCT02284256
• Lead Sponsor: Mallinckrodt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-05
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibrocaps	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
TachoSil	TachoSil	Human fibrinogen and thrombin powder. Single application during surgery

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis (TTH)	Within 5 minutes of treatment

Trial Locations

Locations (15)

Krankenhaus Nordwest GmbH; 🇩🇪 Frankfurt am Main, Germany

Universitaetsklinikum Aachen, RWTH; 🇩🇪 Aachen, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hanover, Germany

Charite Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.; 🇦🇹 Linz, Austria

Universitaetsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

J. W. Goethe Universitaetsklinik Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Klinikum der LMU Muenchen - Campus Grosshadern; 🇩🇪 Muenchen, Germany

Universitaetsklinikum Leipzig AoeR; 🇩🇪 Leipzig, Germany

Klinikum Stuttgart - Katharinenhospital (KH); 🇩🇪 Stuttgart, Germany

Klinikum Rechts der Isar Munich; 🇩🇪 Munich, Germany

Universitaetsklinikum Tuebingen; 🇩🇪 Tuebingen, Germany

Universitaetsklinik Innsbruck; 🇦🇹 Innsbruck, Austria

Medizinische Universitaet Wien AKH; 🇦🇹 Wien, Austria