Status:
COMPLETED
A Study of Fibrocaps in Liver Surgery in the Netherlands
Lead Sponsor:
Mallinckrodt
Conditions:
Postoperative Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ...
Eligibility Criteria
Inclusion
- 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
- 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 x109 PLT/L during screening
- Activated Partial Thromboplastin Time (aPTT) \> 100 seconds during screening
- International Normalized Ratio (INR) \> 2.5 during screening
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01256190
Start Date
December 1 2010
End Date
October 1 2011
Last Update
August 22 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Groningen
Groningen, Netherlands