A Study of Fibrocaps in Liver Surgery in the Netherlands

Postoperative Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256190
• Other study ID #: FC-002 NL
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2010
• Last updated: June 9, 2014
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: ProFibrix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Hemorrhage

Intervention

Biological:
• Fibrocaps (fibrin sealant)
human thrombin and fibrinogen topical powder

Device:
• Gelatin sponge
absorbable gelatin sponge for topical use

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
ProFibrix, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hemostasis	Time from application of treatment to cessation of bleeding	0-10 minutes	No
Secondary	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	Yes
Secondary	Incidence of Hemostasis at 5 Minutes	Number of subjects in each group that achieved hemostasis at pre-specified times after treatment	5 minutes	No
Secondary	Number of Subjects Achieving Hemostasis at 3 Minutes		3 minutes	No
Secondary	Number of Patients Achieving Hemostasis at 10 Minutes		10 minutes	No