The Severe Soft Tissue Bleeding Study

Soft Tissue Bleeding Clinical Trial

Official title:

A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977925
• Other study ID #: 400-08-002
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2009
• Last updated: September 30, 2015
• Start date: August 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: MedsafeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects >= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;

• Presence of an appropriate severe bleeding soft tissue 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;

• Bleeding site 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;

• 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;

• Subjects unwilling to receive blood products;

• Subjects with known immunodeficiency diseases (including known HIV);

• 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 enrollment;

• Female subjects who are pregnant or nursing.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Soft Tissue Bleeding

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 severe bleeding.

Locations

Country	Name	City	State
Australia	Bankstown Hospital	Bankstown
Australia	Flinders Medical Centre	Bedford Park
Australia	The Townsville Hospital	Douglas
Australia	Royal Melbourne Hospital	Parkville
Germany	Department of Surgery, University of Heidelberg	Heidelberg
Germany	Krankenhaus Salem	Heidelberg
Germany	University Hospital of the University of Saarland	Homburg/Saar
Germany	Vincentius-Klinken	Karlsruhe
New Zealand	Auckland City Hospital	Auckland
New Zealand	Auckland City Hospital	Auckland
New Zealand	North Shore Hospital	Auckland
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	The Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	St. James University Hospital	Leeds
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Nottingham City Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

Australia,  Germany,  New Zealand,  United Kingdom, 

References & Publications (2)

Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Erratum to: Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thorac — View Citation

Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-card — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.		Intra-operative	No
Secondary	Proportion of subjects achieving hemostatic success at 10 minutes following randomization		Intra-operative	No
Secondary	Absolute time to hemostasis		Intra-operative	No
Secondary	Proportion of subjects requiring re-treatment at the TBS prior to wound closure		Intra-operative	No
Secondary	Incidence of treatment failures		Intra-operative	No
Secondary	Incidence of adverse events that are potentially related to bleeding at the TBS		Intra-operative through 60 days	Yes
Secondary	Incidence of adverse events that are potentially related to thrombotic events;		Intra-operative through 60 days	Yes
Secondary	Incidence of adverse events		Intra-operative through 60 days	Yes