Hepatic resection or soft tissue dissection MedDRA version: 12.1 Level: LLT Classification code 10042609 Term: Surgery
Conditions
Interventions
Product Name: Fibrocaps™
Product Code: Fibrocaps™
Pharmaceutical Form: Sealant
INN or Proposed INN: Fibrinogen
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number
Sponsors
ProFibrix BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria (pre-surgery) 1. Male or female = 18 years of age 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. Has a life expectancy of at least one year Inclusion Criteria (during surgery) 5. Presence of mild or moderate bleeding/oozing 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 = 100 cm2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Has a known intolerance to blood products or to Fibrocaps components 3. Unwilling to receive human blood products 4. Subject has a known allergy to porcine gelatin 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. 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. Aspartate Aminotransferase or Alanine aminotransferase (AST/ASAT or ALT/ALAT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection where there is no upper limit for these analytes due to the nature of their disease 9. Platelets 100 seconds during screening 11. INR > 2.5 during screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the efficacy of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical ;Secondary Objective: To characterize the safety of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical ;Primary end point(s): Efficacy: 1°: Mean Time to Hemostasis (TTH) of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone 2°: Proportion of subjects achieving hemostasis at 3, 5, and 10 minutes Safety: Compare the overall safety and tolerability of Fibrocaps plus gelatin sponge and gelatin sponge alone, as determined by: • The incidence and severity of treatment-emergent adverse events • The incidence and grade of treatment-emergent clinical laboratory abnormalities • Proportion of subjects developing anti-thrombin antibodies | — |
Countries
Netherlands
Outcome results
None listed