The Severe Soft Tissue Bleeding Study
- Conditions
- Soft Tissue Bleeding
- Interventions
- Biological: Fibrin PadProcedure: Standard of Care
- Registration Number
- NCT00977925
- Lead Sponsor
- Ethicon, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fibrin Pad Fibrin Pad - Standard of Care Standard of Care -
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS. Intra-operative
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving hemostatic success at 10 minutes following randomization Intra-operative Absolute time to hemostasis Intra-operative Proportion of subjects requiring re-treatment at the TBS prior to wound closure Intra-operative Incidence of treatment failures Intra-operative Incidence of adverse events that are potentially related to bleeding at the TBS Intra-operative through 60 days Incidence of adverse events that are potentially related to thrombotic events; Intra-operative through 60 days Incidence of adverse events Intra-operative through 60 days
Trial Locations
- Locations (16)
Flinders Medical Centre
🇦🇺Bedford Park, Australia
Bankstown Hospital
🇦🇺Bankstown, Australia
The Townsville Hospital
🇦🇺Douglas, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Australia
University Hospital of the University of Saarland
🇩🇪Homburg/Saar, Germany
Krankenhaus Salem
🇩🇪Heidelberg, Germany
Department of Surgery, University of Heidelberg
🇩🇪Heidelberg, Germany
Vincentius-Klinken
🇩🇪Karlsruhe, Germany
Auckland City Hospital
🇳🇿Auckland, New Zealand
The Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
North Shore Hospital
🇳🇿Auckland, New Zealand
St Bartholomew's Hospital
🇬🇧London, United Kingdom
St. James University Hospital
🇬🇧Leeds, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom