A study of the superior effect of EVARREST™ Fibrin Sealant Patch as compared to Standard Treatment in controlling bleeding during liver surgery
- Conditions
- Subjects undergoing elective, open, hepatic surgery during which a resection plane is created and wherein an appropriate Target Bleeding Site is identifiedTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-002535-24-GB
- Lead Sponsor
- Ethicon Inc., a Johnson & Johnson Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1.Subjects > 18 years of age, requiring elective or urgent, open hepatic surgery.
2. Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
3. Subjects must be willing to participate in the study, and provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
1.Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
2.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;
3. TBS with major arterial bleeding requiring suture or mechanical ligation;
4. Subjects admitted for trauma surgery;
5. Subject is a transplant patient for fulminant hepatic failure
6. Subject with TBS within an actively infected field;
7. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
8. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
9. Subjects who are known, current alcohol and / or drug abusers;
10. Subjects who have participated in another medical device or investigational drug trial within 30 days of surgery;
11. Female subjects who are pregnant or nursing.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and hemostatic effectiveness of EVARREST Fibrin Sealant Patch versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.;Secondary Objective: Not applicable;Primary end point(s): 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 (latest point in time where EVARREST is visible to confirm hemostasis). Hemostasis is defined as no detectable bleeding at the TBS.;Timepoint(s) of evaluation of this end point: 4 minutes following randomization
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of subjects achieving hemostatic success at 10 minutes following randomization (defined as achievement of hemostasis at 10 minutes and no further bleeding requiring re-treatment prior to wound closure);<br>Absolute time to hemostasis (defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization);<br>Incidence of re-bleeding events from the TBS during the study follow-up; <br>Incidence of adverse events;<br>Incidence of adverse events that are potentially related to thrombotic events<br>;Timepoint(s) of evaluation of this end point: For first secondary endpoint: 10 minutes. Other endpoints throughout study period.