A Study of Fibrocaps in Liver Surgery in the Netherlands
- Conditions
- Postoperative Hemorrhage
- Interventions
- Biological: Fibrocaps (fibrin sealant)Device: Gelatin sponge
- Registration Number
- NCT01256190
- Lead Sponsor
- Mallinckrodt
- 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 and be conducted at 4 sites in the Netherlands.
- 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 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fibrocaps + Gelatin sponge Gelatin sponge Topical Fibrocaps powder followed by application of gelatin sponge Fibrocaps + Gelatin sponge Fibrocaps (fibrin sealant) Topical Fibrocaps powder followed by application of gelatin sponge Gelatin Sponge Gelatin sponge approved device for surgical bleeding
- Primary Outcome Measures
Name Time Method Time to Hemostasis 0-10 minutes Time from application of treatment to cessation of bleeding
- Secondary Outcome Measures
Name Time Method Number of Patients Achieving Hemostasis at 10 Minutes 10 minutes Safety 28 days Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS)
Number of Subjects Achieving Hemostasis at 3 Minutes 3 minutes Incidence of Hemostasis at 5 Minutes 5 minutes Number of subjects in each group that achieved hemostasis at pre-specified times after treatment
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands