The Fibrin Pad Liver Study

Hemorrhage Clinical Trial

Official title:

A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166243
• Other study ID #: 400-10-001
• Secondary ID: 2010-019427-58
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2010
• Last updated: January 17, 2014
• Start date: July 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2014
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-InstitutNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects > 18 years of age, requiring elective or urgent, open hepatic surgery

• Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon

• Subjects must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

• Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure

• TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product

• TBS with major arterial bleeding requiring suture or mechanical ligation

• Subjects admitted for trauma surgery

• Subject is a transplant patient for fulminant hepatic failure

• Subject with TBS within an actively infected field

• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine

• Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products

• Subjects who are known, current alcohol and / or drug abusers

• Subjects who have participated in another investigational drug or device research study within 30 days of surgery

• Female subjects who are pregnant or nursing

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Biological:
• Fibrin Pad
Fibrin Pad is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

Procedure:
• Standard of Care
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	The Alfred	Melbourne	Victoria
Australia	Queen Elizabeth Hospital	Woodville	South Australia
Germany	University Hospital of the University of Saarland	Strasse
Netherlands	University Medical Center	Groningen
New Zealand	Auckland City Hospital	Grafton
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	OMRIX Biopharmaceuticals

Countries where clinical trial is conducted

Australia,  Germany,  Netherlands,  New Zealand,  United Kingdom, 

References & Publications (1)

Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HP — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).		Intra-operative	No
Secondary	Proportion of subjects achieving hemostasis success at 10-minutes following randomization.		Intra-operative	No
Secondary	Absolute time to hemostasis		Intraoperative	No
Secondary	Subjects requiring re-treatment		Intraoperative	No
Secondary	Incidence of adverse events potentially related to re-bleeding at TBS		Intraoperative through 60 days	Yes
Secondary	Incidence of adverse events potentially related to thrombotic events		Intraoperative through 60 days	Yes
Secondary	Incidence of adverse events		Intraoperative through 60 days	Yes