The Severe Soft Tissue Bleeding Study

NCT ID: NCT00977925

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-03-31

Brief 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.

Conditions

Soft Tissue Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fibrin Pad

Group Type: EXPERIMENTAL

Fibrin Pad

Intervention Type: BIOLOGICAL

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).

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: PROCEDURE

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

Interventions

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).

Intervention Type: BIOLOGICAL

Standard of Care

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Hart, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Bankstown Hospital

Bankstown, , Australia

Flinders Medical Centre

Bedford Park, , Australia

The Townsville Hospital

Douglas, , Australia

Royal Melbourne Hospital

Parkville, , Australia

University Hospital of the University of Saarland

Homburg/Saar, Homburg/Saar, Germany

Department of Surgery, University of Heidelberg

Heidelberg, , Germany

Krankenhaus Salem

Heidelberg, , Germany

Vincentius-Klinken

Karlsruhe, , Germany

Auckland City Hospital

Auckland, , New Zealand

Auckland City Hospital

Auckland, , New Zealand

North Shore Hospital

Auckland, , New Zealand

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, , United Kingdom

Countries

Australia; Germany; New Zealand; United Kingdom

References

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 Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Oct;39(10):2610. doi: 10.1007/s00268-015-3163-9. No abstract available.

Reference Type: RESULT

PMID: 26216641 (View on PubMed)

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-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Nov;39(11):2663-9. doi: 10.1007/s00268-015-3106-5.

Reference Type: RESULT

PMID: 26041587 (View on PubMed)

Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21.

Reference Type: DERIVED

PMID: 26636489 (View on PubMed)

Other Identifiers

400-08-002

Identifier Type: -

Identifier Source: org_study_id