Clinical trial NCT00977925: The Severe Soft Tissue Bleeding Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Soft Tissue Bleeding
Keywords: Hemostasis
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.
timeFrame: Intra-operative
Secondary outcomes:
measure: Proportion of subjects achieving hemostatic success at 10 minutes following randomization
timeFrame: Intra-operative
measure: Absolute time to hemostasis
timeFrame: Intra-operative
measure: Proportion of subjects requiring re-treatment at the TBS prior to wound closure
timeFrame: Intra-operative
measure: Incidence of treatment failures
timeFrame: Intra-operative
measure: Incidence of adverse events that are potentially related to bleeding at the TBS
timeFrame: Intra-operative through 60 days
measure: Incidence of adverse events that are potentially related to thrombotic events;
timeFrame: Intra-operative through 60 days
measure: Incidence of adverse events
timeFrame: Intra-operative through 60 days
Other outcomes:
Locations:
city: Bankstown
country: Australia
facility: Bankstown Hospital
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Douglas
country: Australia
facility: The Townsville Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Heidelberg
country: Germany
facility: Department of Surgery, University of Heidelberg
city: Heidelberg
country: Germany
facility: Krankenhaus Salem
city: Homburg/Saar
country: Germany
facility: University Hospital of the University of Saarland
city: Karlsruhe
country: Germany
facility: Vincentius-Klinken
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Edinburgh
country: United Kingdom
facility: The Royal Infirmary of Edinburgh
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Ethicon, Inc.
name: James Hart, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Nov;39(11):2663-9. doi: 10.1007/s00268-015-3106-5.
citation: 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.