A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
- Conditions
- Haemostasisbleeding from the liver10019818
- Registration Number
- NL-OMON34280
- Lead Sponsor
- Omrix Biopharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Subjects aged 18 years or over, requiring elective or urgent open hepatic surgery
2. Presence of an appropriate bleeding parenchymal Target Bleeding Site (TBS) as identified intraoperatively by the surgeon.
3. Subjects must be willing to participate in the study, and provide written informed consent.
1. Subjects with any intraoperative findings identified by the surgeon that may preclude conduct of the study procedure*
2. TBS is from large defects in arteries or vein 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*
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*
9. Subjects who are known, current alcohol and / or drug abusers*
10. Subjects who have participated in another investigational drug or device research study within 30 days of surgery*
11. Female subjects who are pregnant or nursing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the proportion of subjects achieving hemostasis at<br /><br>the TBS at 4-miniutes<br /><br>following randomization and with no re-bleeding requiring treatment at the TBS<br /><br>any time prior to the<br /><br>initiation of wound closure (last point in time where FP will be visible to<br /><br>confirm hemostasis).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints of this study include:<br /><br>- Proportion of subjects achieving hemostatic success at 10 minutes following<br /><br>randomization;<br /><br>(defined as achievement of hemostasis at 10 minutes and no further bleeding<br /><br>requiring retreatment<br /><br>prior to wound closure);<br /><br>- Absolute time to hemostasis (defined as the absolute time to achieve<br /><br>hemostasis at or after 4<br /><br>minutes from randomization);<br /><br>- The proportion of subjects who after initial hemostatic success at 4 minutes<br /><br>have<br /><br>breakthrough bleeding requiring treatment;<br /><br>- The proportion of subjects who after the initial establishment of hemostasis<br /><br>(after 4 minutes)<br /><br>have breakthrough bleeding requiring treatment;<br /><br>- Incidence of adverse events potentially related to re-bleeding at the TBS;<br /><br>- Incidence of adverse events that are potentially related to thrombotic events;<br /><br>- Incidence of adverse events.</p><br>