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

• 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: Instituto Grifols, S.A.
• Information provided by (Responsible Party): Grifols Biologicals, LLC ( Instituto Grifols, S.A. )

Tracking Information

• First Submitted Date: December 18, 2012
• First Posted Date: December 21, 2012
• Results First Submitted Date: December 16, 2016
• Results First Posted Date: February 8, 2017
• Last Update Posted Date: February 8, 2017
• Study Start Date: March 2013
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
• Condition: Parenchymous Tissue Surgical Bleeding

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2016): 325
• Original Estimated Enrollment (submitted: December 18, 2012): 344
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hungary, Russian Federation, Serbia, United States

Administrative Information

• NCT Number: NCT01754480
• Other Study ID Numbers: IG1102
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Grifols Biologicals, LLC ( Instituto Grifols, S.A. )
• Study Sponsor: Instituto Grifols, S.A.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Grifols Biologicals, LLC
• Verification Date: December 2016