A Study of Fibrocaps in Liver Surgery in the Netherlands

NCT ID: NCT01256190

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-10-31

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.

Conditions

Postoperative Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fibrocaps + Gelatin sponge

Topical Fibrocaps powder followed by application of gelatin sponge

Group Type: EXPERIMENTAL

Fibrocaps (fibrin sealant)

Intervention Type: BIOLOGICAL

human thrombin and fibrinogen topical powder

Gelatin sponge

Intervention Type: DEVICE

absorbable gelatin sponge for topical use

Gelatin Sponge

approved device for surgical bleeding

Group Type: ACTIVE_COMPARATOR

Gelatin sponge

Intervention Type: DEVICE

absorbable gelatin sponge for topical use

Interventions

Fibrocaps (fibrin sealant)

human thrombin and fibrinogen topical powder

Intervention Type: BIOLOGICAL

Gelatin sponge

absorbable gelatin sponge for topical use

Intervention Type: DEVICE

Other Intervention Names

PRO-0601; Fibrin Sealant; Spongostan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Frohna, MD, PhD

Role: STUDY_DIRECTOR

Mallinckrodt

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

References

Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

Reference Type: DERIVED

PMID: 38695613 (View on PubMed)

Other Identifiers

FC-002 NL

Identifier Type: -

Identifier Source: org_study_id