Phase 3
Completed N=102
The EVARREST® Fibrin Sealant Patch Liver Study
Source: ClinicalTrials.gov NCT01993888 ↗Enrolled (actual)
102
Serious AEs
27.5%
Results posted
Jul 2016
Primary outcomePrimary: Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization — 48; 24 participants with hemostatic success — p=<.0001
◆ Published Evidence
Established
29citations · ~3 / year
A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection.
Summary
To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
Linked Publications (2)
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A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection.
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Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization |
48; 24 | <.0001 sig |
| SECONDARY Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization |
49; 42 | — |
| SECONDARY Absolute Time to Hemostasis |
4.0; 4.7 | — |
| SECONDARY Incidence of Re-bleeding Events From the TBS During the Study Follow-up |
1; 24; 0; 3; 1; 1 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
45; 50; 12; 16; 8; 6 | — |
| SECONDARY Incidence of Adverse Events That Were Potentially Related to Thrombotic Events |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.
- Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
- Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)
Exclusion Criteria
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
- TBS 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 EVARREST® to blood flow and pressure during healing and absorption of the product;
- TBS with major arterial bleeding requiring suture or mechanical ligation;
- Subjects admitted for trauma surgery;
- Subject is a transplant patient for fulminant hepatic failure
- 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 or is unwilling to receive blood products;
- Subjects who are known, current alcohol and / or drug abusers;
- Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
- Female subjects who are pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT01993888) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.