Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Takeda
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
Need for additional supportive hemostatic treatment
Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes
You may not be if
Indication for emergency surgery
Known coagulopathy (as judged relevant by the investigator)
Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
Patient unwilling to receive blood products
Known current alcohol or drug abuse
Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential
Dry surgical field of the targeted application area
Occurrence of any serious surgical complication
Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding
Application of topical hemostatic material on the liver resection wound
Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment
Clareo Health | TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery