Phase 3 Study of Fibrocaps™ in Surgical Bleeding (FINISH-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ProFibrix, Inc.
ClinicalTrials.gov Identifier:
NCT01527357
First received: January 26, 2012
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery.

This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial that will be conducted at clinical trial sites in the European Union and United States.


Condition Intervention Phase
Mild or Moderate Surgical Bleeding
Biological: Fibrocaps (PRO-0601)
Device: Gelatin sponge
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

Resource links provided by NLM:


Further study details as provided by ProFibrix, Inc.:

Primary Outcome Measures:
  • Time to Hemostasis (TTH) [ Time Frame: Within 5 minutes of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence, severity and relationship of Adverse Events [ Time Frame: During 4 wks post-treatment ] [ Designated as safety issue: Yes ]
  • Incidence of Hemostasis [ Time Frame: 3 and 5 minutes post-treatment ] [ Designated as safety issue: No ]

Enrollment: 719
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrocaps (PRO-0601)
Fibrocaps (PRO-0601) powder plus gelatin sponge
Biological: Fibrocaps (PRO-0601)
Human fibrinogen and thrombin powder Single application during surgery
Other Names:
  • PRO-0601
  • Fibrin sealant
Device: Gelatin sponge
Single application during surgery
Other Name: Gelfoam, Spongostan
Active Comparator: Gelatin sponge
Gelatin sponge (e.g., Gelfoam, Spongostan)
Device: Gelatin sponge
Single application during surgery
Other Name: Gelfoam, Spongostan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
  2. Subject is undergoing one of the 4 surgical procedures described
  3. Subject age is >18 years at time of consent
  4. If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
  5. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
  6. Subject has not received blood transfusion between screening and study treatment
  7. Presence of mild to moderate surgical bleeding
  8. Absence of intra-operative complications
  9. No intra-operative use of a topical hemostat containing thrombin prior to study treatment
  10. Approximate bleeding site surface area of less than or equal to 100 cm2

Exclusion Criteria:

  1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
  2. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
  3. Subject has known allergy to porcine gelatin
  4. Subject is unwilling to receive blood products
  5. 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, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
  6. Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit for these analytes due to the nature of their disease
  7. Platelets < 100 x109 PLT/L during screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527357

  Show 48 Study Locations
Sponsors and Collaborators
ProFibrix, Inc.
Investigators
Study Director: Paul Frohna, MD, PhD ProFibrix, Inc.
Principal Investigator: Robert J Porte, MD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: ProFibrix, Inc.
ClinicalTrials.gov Identifier: NCT01527357     History of Changes
Other Study ID Numbers: FC-004
Study First Received: January 26, 2012
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ProFibrix, Inc.:
fibrin sealant
thrombin
fibrinogen
hemostasis

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Fibrin Foam
Fibrin Tissue Adhesive
Gelatin Sponge, Absorbable
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014