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Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

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ClinicalTrials.gov Identifier: NCT01754480
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals, LLC ( Instituto Grifols, S.A. )

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 21, 2012
Results First Submitted Date  ICMJE December 16, 2016
Results First Posted Date  ICMJE February 8, 2017
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start [ Time Frame: From start of treatment until 4 minutes after treatment start ]
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Proportion of subjects achieving hemostasis within four minutes after treatment start [ Time Frame: From start of treatment until 4 minutes after treatment start ]
Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start [ Time Frame: From start of treatment until 3 minutes after treatment start ]
    Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
  • Time to Hemostasis [ Time Frame: From start of treatment until 10 minutes after treatment start ]
    Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
  • Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points [ Time Frame: From start of treatment until 10 minutes after treatment start ]
    Cumulative proportion of subjects having achieved hemostasis by each of the following time points:
    • At 2 minutes following start of study treatment
    • At 5 minutes following start of study treatment
    • At 7 minutes following start of study treatment
    • At 10 minutes following start of study treatment
  • Prevalence of Treatment Failures [ Time Frame: From start of treatment until 10 minutes after treatment start ]
    Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
Official Title  ICMJE A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Parenchymous Tissue Open Surgeries
Brief Summary This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Parenchymous Tissue Surgical Bleeding
Intervention  ICMJE
  • Biological: Fibrin Sealant Grifols
    Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
  • Device: Surgicel®
    Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
    Other Names:
    • Fibrillar absorbable hemostat
    • Oxidized regenerated cellulose hemostat
Study Arms  ICMJE
  • Experimental: Fibrin Sealant Grifols
    Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
    Intervention: Biological: Fibrin Sealant Grifols
  • Active Comparator: Surgicel®
    Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
    Intervention: Device: Surgicel®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
325
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
344
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
  • Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
  • A target bleeding site can be identified.
  • Target bleeding site is identified on the cut raw liver surface (resection area).
  • Target bleeding site has moderate bleeding according to the Investigator's judgment.

Exclusion Criteria:

  • Require hepatic resection due to trauma.
  • Infection in the anatomic surgical area.
  • History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
  • Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component.
  • Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
  • Receiving an organ transplant during the same surgical procedure.
  • Undergone a therapeutic surgical procedure within 30 days from the screening visit.
  • A target bleeding site cannot be identified.
  • The target bleeding site has a mild or severe bleeding.
  • Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
  • Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Russian Federation,   Serbia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754480
Other Study ID Numbers  ICMJE IG1102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grifols Biologicals, LLC ( Instituto Grifols, S.A. )
Study Sponsor  ICMJE Instituto Grifols, S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Grifols Biologicals, LLC
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP