Phase 2
Completed N=56
A Study of Fibrocaps in Liver Surgery in the Netherlands
Source: ClinicalTrials.gov NCT01256190 ↗Enrolled (actual)
56
Serious AEs
25.0%
Results posted
May 2014
Primary outcomePrimary: Time to Hemostasis — 2.2; 4.4 minutes — p=0.004
Summary
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis |
2.2; 4.4 | 0.004 sig |
| SECONDARY Safety |
31; 10 | 0.31 |
| SECONDARY Incidence of Hemostasis at 5 Minutes |
37; 12 | .022 sig |
| SECONDARY Number of Subjects Achieving Hemostasis at 3 Minutes |
30; 9 | 0.113 |
| SECONDARY Number of Patients Achieving Hemostasis at 10 Minutes |
39; 14 | .025 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 years of age
- Subjects who are able and willing to provide written and signed informed consent
- Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- Has a life expectancy of at least one year
- 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
Exclusion Criteria
- Pregnant or lactating women
- Has a known intolerance to blood products or to Fibrocaps components
- Unwilling to receive human blood products
- Subject has a known allergy to porcine gelatin
- 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
- 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
- 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
- Platelets(PLT) 100 seconds during screening
- International Normalized Ratio (INR) > 2.5 during screening
Data sourced from ClinicalTrials.gov (NCT01256190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.