NCT01256190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 15, 2014

Completed
Last Updated

August 22, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

December 6, 2010

Results QC Date

April 11, 2013

Last Update Submit

July 22, 2016

Conditions

Postoperative Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Time to Hemostasis

    Time from application of treatment to cessation of bleeding

    0-10 minutes

Secondary Outcomes (4)

  • Safety

    28 days

  • Incidence of Hemostasis at 5 Minutes

    5 minutes

  • Number of Subjects Achieving Hemostasis at 3 Minutes

    3 minutes

  • Number of Patients Achieving Hemostasis at 10 Minutes

    10 minutes

Study Arms (2)

Fibrocaps + Gelatin sponge

EXPERIMENTAL

Topical Fibrocaps powder followed by application of gelatin sponge

Biological: Fibrocaps (fibrin sealant)Device: Gelatin sponge

Gelatin Sponge

ACTIVE COMPARATOR

approved device for surgical bleeding

Device: Gelatin sponge

Interventions

Fibrocaps (fibrin sealant)BIOLOGICAL

human thrombin and fibrinogen topical powder

Also known as: PRO-0601, Fibrin Sealant
Fibrocaps + Gelatin sponge
Gelatin spongeDEVICE

absorbable gelatin sponge for topical use

Also known as: Spongostan
Fibrocaps + Gelatin spongeGelatin Sponge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 38695613DERIVED

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Fibrin Tissue AdhesiveGelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSurgical SpongesSurgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Lawrence Hill
Organization
Mallinckrodt
lawrence.hill@mallinckrodt.com
908-238-6370

Study Officials

  • Paul Frohna, MD, PhD

    Mallinckrodt

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 8, 2010

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

August 22, 2016

Results First Posted

May 15, 2014

Record last verified: 2016-07

Locations

NL(1)