A prospective, non-controlled, open-label study to assess the safety and effectiveness of Fibrocaps* in subjects undergoing liver resection.

Phase 2

Recruiting

• Conditions: Liver resection; liver surgery; 10019818

• Registration Number: NL-OMON33792
• Lead Sponsor: ProFibrix

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Signed the written informed consent form before first screening procedure;
2. Males and females aged >= 18 years and <= 75 years;
3. Scheduled to undergo open liver resection for any reason except trauma;
4. Uses adequate contraception during the course of the study
5. Has a life expectancy of at least one year.
6. Has a normal liver background (absence of extensive fibrosis and cirrhosis)
Intraoperative Inclusion Criteria:
7. Presence of mild or moderate bleeding/oozing which control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical;
8. Absence of intra-operative complications other than bleeding at the resection site which may, in the opinion of the investigator, interfere with assessment of effectiveness or safety.

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 x109 PLT/L;
12. APTT > 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety variables include:<br /><br>• Incidence, nature and severity of adverse events;<br /><br>• Presence of bile in post-operative drain fluid;<br /><br>• Changes in vital signs after Fibrocaps*application.<br /><br>• Changes from baseline in clinical and laboratory values;<br /><br>• HIV, HAV, HBV and HCV infection rateviral status 12 weeks after treatment;<br /><br>• Development of Anti-Thrombin Antibodies at 4 and 12 weeks after treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Effectiveness parameters include:<br /><br>• Time to Haemostasis is defined as the absolute time between the start of<br /><br>application of Fibrocaps* and the time when haemostasis is achieved.<br /><br>• Volume of drain fluid originated atby the wound and not by ascites at 24 and<br /><br>48 hours post-surgery.<br /><br>Exploratory parameters:<br /><br>• Approximate dose of Fibrocaps per cm 2<br /><br>• Effect of manual pressure application, when applied.<br /><br>• Effect of the use of generally available materials used for compression, when<br /><br>used.<br /><br>• Effect of the Fibrocaps*application method<br /><br>• Validate the prototype application device.<br /><br>• Other recommendations on the use of the applicator device made by principal<br /><br>investigators.</p><br>