Status:
COMPLETED
Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection
Lead Sponsor:
Aesculap AG
Conditions:
Hemostasis
Liver Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The prim...
Detailed Description
During liver resection the control of bleeding is a major concern. The liver is predisposed to diffuse bleeding because of its extreme vascularity. Locally applicable agents (haemostats) are in use in...
Eligibility Criteria
Inclusion
- Inclusion:
- Age: \> 18 years
- Gender: male / female
- 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
- Exclusion:
- Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor
- 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
- Missing signed written informed consent to participate in the study
- Exclusion criteria to be checked during surgery (liver resection):
- Resection area estimated by operating surgeon \< 16cm2
- Infected wound area
- Persistant major bleeding after primary haemostasis
- No bleeding after resection
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00918619
Start Date
January 1 2010
End Date
January 1 2011
Last Update
May 28 2015
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinik für Chirurgie, Medizinische Universität Graz
Graz, Austria, 8036
2
Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Berlin, Germany, 13353
3
Krankenhaus Nordwest, Klinik für Allgemein-, Viszeral- und Minimal Invasive Chirurgie
Frankfurt, Germany, 60488
4
Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie
Frankfurt am Main, Germany, 60590