The EVARREST® Fibrin Sealant Patch Liver Study
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|ClinicalTrials.gov Identifier: NCT01993888|
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhage||Biological: EVARREST® Fibrin Sealant Patch Other: Standard of Care (SoC)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||September 2014|
Experimental: EVARREST® Fibrin Sealant Patch
EVARREST® Fibrin Sealant Patch 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).
Biological: EVARREST® Fibrin Sealant Patch
Standard of Care (SoC)
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
Other: Standard of Care (SoC)
- Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization [ Time Frame: Intraoperative, 4 minutes following randomization ]Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.
- Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization [ Time Frame: Intraoperative, 10 minutes following randomization ]Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.
- Absolute Time to Hemostasis [ Time Frame: Intraoperative, an average of 4.2 minutes following randomization ]The absolute time to achieve hemostasis at or after 4 minutes from randomization.
- Incidence of Re-bleeding Events From the TBS During the Study Follow-up [ Time Frame: Up to 60-days following surgery ]
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 60-days following surgery ]
- Incidence of Adverse Events That Were Potentially Related to Thrombotic Events [ Time Frame: Up to 60-days following surgery ]Number of participants with adverse events that were potentially related to thrombic events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993888
|Study Director:||Richard Kocharian, MD||Ethicon, Inc.|