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 range18 Years
SexALL
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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.
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