Back to resultsA Study of Fibrocaps in Liver Surgery in the Netherlands
Primary Purpose
Postoperative Hemorrhage
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Fibrocaps (fibrin sealant)
Gelatin sponge
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Hemorrhage
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 x109 PLT/L during screening
- Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening
- International Normalized Ratio (INR) > 2.5 during screening
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fibrocaps + Gelatin sponge
Gelatin Sponge
Arm Description
Topical Fibrocaps powder followed by application of gelatin sponge
approved device for surgical bleeding
Outcomes
Primary Outcome Measures
Time to Hemostasis
Time from application of treatment to cessation of bleeding
Secondary Outcome Measures
Safety
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)
Incidence of Hemostasis at 5 Minutes
Number of subjects in each group that achieved hemostasis at pre-specified times after treatment
Number of Subjects Achieving Hemostasis at 3 Minutes
Number of Patients Achieving Hemostasis at 10 Minutes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01256190
Brief Title
A Study of Fibrocaps in Liver Surgery in the Netherlands
Official Title
A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibrocaps + Gelatin sponge
Arm Type
Experimental
Arm Description
Topical Fibrocaps powder followed by application of gelatin sponge
Arm Title
Gelatin Sponge
Arm Type
Active Comparator
Arm Description
approved device for surgical bleeding
Intervention Type
Biological
Intervention Name(s)
Fibrocaps (fibrin sealant)
Other Intervention Name(s)
PRO-0601, Fibrin Sealant
Intervention Description
human thrombin and fibrinogen topical powder
Intervention Type
Device
Intervention Name(s)
Gelatin sponge
Other Intervention Name(s)
Spongostan
Intervention Description
absorbable gelatin sponge for topical use
Primary Outcome Measure Information:
Title
Time to Hemostasis
Description
Time from application of treatment to cessation of bleeding
Time Frame
0-10 minutes
Secondary Outcome Measure Information:
Title
Safety
Description
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)
Time Frame
28 days
Title
Incidence of Hemostasis at 5 Minutes
Description
Number of subjects in each group that achieved hemostasis at pre-specified times after treatment
Time Frame
5 minutes
Title
Number of Subjects Achieving Hemostasis at 3 Minutes
Time Frame
3 minutes
Title
Number of Patients Achieving Hemostasis at 10 Minutes
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 x109 PLT/L during screening
Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening
International Normalized Ratio (INR) > 2.5 during screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Frohna, MD, PhD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Study of Fibrocaps in Liver Surgery in the Netherlands
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