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Table 2 Eligibility Criteria

From: Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study

Inclusion Criteria

Exclusion Criteria

▪ Age: >18 years

▪ Patients with an indication for liver resection (segmental or non-segmental)

▪ Willing and able to complete the clinical trial procedures, as described in the protocol

▪ Signed written informed consent to participate in this clinical trial

Criteria to be checked at screening visit:

▪ Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumour

▪ 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 tranexamix acid, activated factor VII, and aprotinine

▪ Known allergy or hypersensitivity to a component of the investigational treatments Sangustop® or Tachosil®, 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:

▪ Resection area estimated by operating surgeon <16 cm2

▪ Infected wound area

▪ Persistent major bleeding after primary haemostasis

▪ No bleeding after resection