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

Surgical Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284256
• Other study ID #: FC-005
• Secondary ID: 2014-000816-32
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2014
• Last updated: August 14, 2017
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2017
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Bleeding

Intervention

Drug:
• Fibrocaps

• TachoSil

Locations

Country	Name	City	State
Austria	Universitaetsklinik Innsbruck	Innsbruck
Austria	Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.	Linz
Austria	Medizinische Universitaet Wien AKH	Wien
Germany	Universitaetsklinikum Aachen, RWTH	Aachen
Germany	Charite Campus Virchow-Klinikum	Berlin
Germany	J. W. Goethe Universitaetsklinik Frankfurt	Frankfurt am Main
Germany	Krankenhaus Nordwest GmbH	Frankfurt am Main
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hanover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Leipzig AoeR	Leipzig
Germany	Klinikum der LMU Muenchen - Campus Grosshadern	Muenchen
Germany	Klinikum Rechts der Isar Munich	Munich
Germany	Klinikum Stuttgart - Katharinenhospital (KH)	Stuttgart
Germany	Universitaetsklinikum Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hemostasis (TTH)		Within 5 minutes of treatment