A Phase 2 , Randomized , Single - Blind , Controlled , Comparative Efficacy and Safety Study of Topical Fibrocaps * and Gelatin Sponge in Surgical hemostasis in the Netherlands
- Conditions
- Liver resectionLiver surgery10019818
- Registration Number
- NL-OMON36279
- Lead Sponsor
- ProFibrix
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1 . Male or female aged >= 18 years
2 . Subjects who are able and willing to provide written and signed informed consent
3 . Willing to use a medically accepted form of contraception from the time of consent to completion of all follow - up study visits
4 . A life expectancy of at least one year;Intra-operative Inclusion Criteria
5 . Presence of mild or moderate bleeding and control by conventional surgical techniques including but not limited to suture , ligature , and cautery is ineffective or impractical
6 . Absence of intra - operative complications other than bleeding which , in the opinion of the Investigator , may interfere with the assessment of efficacy or safety
7. No intra-operative use of a topical hemostat containing thrombin
8. Target Bleeding Site surface area of less than approximately 100 cm2.
1 . Pregnant or lactating women
2 . Has a known intolerance to blood products or components to Fibrocaps
3 . Unwilling to receive human blood products
4 . Subject has a known allergy to porcine gelatin
5 . 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 . Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery
7 . Has any clinically-significant , coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator
8 . Platelets < 100 x 10E9 PLT / L during screening
9 . aPTT > 100 seconds during screening
10 . INR > 2.5 during screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is mean Time to Haemostasis of Fibrocaps plus<br /><br>gelatin sponge, as compared to gelatin sponge alone. </p><br>
- Secondary Outcome Measures
Name Time Method