A Study of Fibrocaps in Liver Surgery in the Netherlands

Mallinckrodt

Status and phase: Completed; Phase 2

Conditions: Postoperative Hemorrhage

Treatments: Device: Gelatin sponge; Biological: Fibrocaps (fibrin sealant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01256190

FC-002 NL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Fibrocaps + Gelatin sponge

Experimental group

Description:

Topical Fibrocaps powder followed by application of gelatin sponge

Treatment:

Biological: Fibrocaps (fibrin sealant)

Device: Gelatin sponge

Gelatin Sponge

Active Comparator group

Description:

approved device for surgical bleeding

Treatment:

Device: Gelatin sponge