A Study of Fibrocaps in Liver Surgery in the Netherlands

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Hemorrhage
• Intervention / Treatment: Biological: Fibrocaps (fibrin sealant); Device: Gelatin sponge

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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
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

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. Platelets(PLT) < 100 x109 PLT/L during screening
9. Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening
10. International Normalized Ratio (INR) > 2.5 during screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fibrocaps + Gelatin sponge; Topical Fibrocaps powder followed by application of gelatin sponge	Biological: Fibrocaps (fibrin sealant); human thrombin and fibrinogen topical powder; Other Names: Fibrin Sealant; PRO-0601; Device: Gelatin sponge; absorbable gelatin sponge for topical use; Other Names: Spongostan
ACTIVE_COMPARATOR: Gelatin Sponge; approved device for surgical bleeding	Device: Gelatin sponge; absorbable gelatin sponge for topical use; Other Names: Spongostan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hemostasis	Time from application of treatment to cessation of bleeding	0-10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	28 days
Incidence of Hemostasis at 5 Minutes	Number of subjects in each group that achieved hemostasis at pre-specified times after treatment	5 minutes
Number of Subjects Achieving Hemostasis at 3 Minutes		3 minutes
Number of Patients Achieving Hemostasis at 10 Minutes		10 minutes

Collaborators and Investigators

• Sponsor: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (ESTIMATE): December 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Hemostatics; Coagulants; Fibrin Tissue Adhesive; Fibrin Foam
• Other Study ID Numbers: FC-002 NL