Liver resection liver surgery
Conditions
Interventions
During surgery, Fibrocaps* will be applied as needed to the resected surface.
In case bleeding/oozing has not stopped 10 minutes after applying Fibrocaps*,
the surgeon will use local standard practi
Sponsors
ProFibrix
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed the written informed consent form before first screening procedure; 2. Males and females aged >= 18 years and
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women and women planning to become pregnant in the 3 months after surgery; 2. Has a known intolerance to blood products or to Fibrocaps components; 3. Unwilling to receive human blood products; 4. Has any psychiatric problems, in the opinion of the investigator, likely to invalidate informed consent; 5. Has a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol; 6. Unwilling and/or unable to comply with all aspects of the protocol for the duration of the study; 7. a) currently participating or b) has participated in another clinical study involving another IMP within 4 weeks of the start of this trial or c) is planning participation in another clinical trial in the 4 weeks after surgery, which in the opinion of the investigator may interfere with assessment of effectiveness or safety.; 8. Has any other known coagulation disorder which may interfere with the assessment of effectiveness according to the investigator; 9. Child Pugh score B or C; 10. ASAT and/or ALAT > 3 x upper limit normal range; 11. Thrombocytopenia, 100 seconds; 13. INR > 2 x upper limit normal range; 14. Use of anticoagulant therapy other than routine prophylaxis for DVT, use of platelet aggregation inhibitors, thrombolytics or anticipated use of these agents after surgery. 15. Treatment with cyclosporine 16. Healthy donors scheduled to undergo liver resection for transplantation purposes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables include: • Incidence, nature and severity of adverse events; • Presence of bile in post-operative drain fluid; • Changes in vital signs after Fibrocaps*application. • Changes from baseline in clinical and laboratory values; • HIV, HAV, HBV and HCV infection rateviral status 12 weeks after treatment; • Development of Anti-Thrombin Antibodies at 4 and 12 weeks after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness parameters include: • Time to Haemostasis is defined as the absolute time between the start of application of Fibrocaps* and the time when haemostasis is achieved. • Volume of drain fluid originated atby the wound and not by ascites at 24 and 48 hours post-surgery. Exploratory parameters: • Approximate dose of Fibrocaps per cm 2 • Effect of manual pressure application, when applied. • Effect of the use of generally available materials used for compression, when used. • Effect of the Fibrocaps*application method • Validate the prototype application device. • Other recommendations on the use of the applicator device made by principal investigators. | — |
Countries
Netherlands
Outcome results
None listed