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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527357
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):

Brief Summary:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 719 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Study Start Date : May 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Gelatin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to Hemostasis (TTH) [ Time Frame: Within 5 minutes of treatment ]

Secondary Outcome Measures :
  1. Incidence, severity and relationship of Adverse Events [ Time Frame: During 4 wks post-treatment ]
  2. Incidence of Hemostasis [ Time Frame: 3 and 5 minutes post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01527357

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Sponsors and Collaborators
Study Director: Paul Frohna, MD, PhD Mallinckrodt
Principal Investigator: Robert J Porte, MD, PhD University Medical Center Groningen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mallinckrodt Identifier: NCT01527357     History of Changes
Other Study ID Numbers: FC-004
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014

Keywords provided by Mallinckrodt:
fibrin sealant

Additional relevant MeSH terms:
Pathologic Processes
Fibrin Tissue Adhesive
Gelatin Sponge, Absorbable
Fibrin Foam