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Trial record 1 of 1 for:    NCT01527357
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Phase 3 Study of Fibrocaps™ in Surgical Bleeding (FINISH-3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527357
First Posted: February 7, 2012
Last Update Posted: June 18, 2014
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.
Information provided by (Responsible Party):
Mallinckrodt
  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
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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01527357


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01527357     History of Changes
Other Study ID Numbers: FC-004
First Submitted: January 26, 2012
First Posted: February 7, 2012
Last Update Posted: June 18, 2014
Last Verified: June 2014

Keywords provided by Mallinckrodt:
fibrin sealant
thrombin
fibrinogen
hemostasis

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