Standard of Care Versus Hemopatch® During Liver Resection (NCT03166683) | Clinical Trial Compass
UnknownNot Applicable
Standard of Care Versus Hemopatch® During Liver Resection
284 participantsStarted 2017-12
Plain-language summary
This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: ≥18 years.
* Patients with an indication for open liver resection (segmental or non-segmental).
* Target bleeding site of generalized bleeding that persists on the cut surface of the liver in which hemostasis cannot be achieved by conventional methods.
* Willing and able to complete the clinical trial procedures, as described in the protocol.
* Signed written informed consent to participate in this clinical trial.
Exclusion Criteria:
* Presence of coagulation disorder, Klatskin tumour. Cirrhosis, re-hepatectomies and biliary resections
* Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints.
* Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamic acid, activated factor VII, fibrinogen and aprotinin.
* Known allergy or hypersensitivity to a component of the investigational treatments Hemopatch® ,to riboflavin or to proteins of bovine origin.
* Pregnancy or breast-feeding.
* Inability to understand the nature and the extent of the trial and the procedures required.
Criteria to be checked during surgery (intraoperative exclusion criteria):
* Infected wound area.
* Persistent major bleeding after primary hemostasis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Control of bile leakage
Timeframe: From day 1 to day 4
Trial details
NCT IDNCT03166683
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla