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

This study has been completed.
Sponsor:
Collaborator:
Instituto Grifols, S.A.
Information provided by (Responsible Party):
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT01731938
First received: November 19, 2012
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. The purpose of this study is to demonstrate that FS 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 FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.

Condition Intervention Phase
Soft Tissue Surgical Bleeding
Biological: Fibrin Sealant (FS) Grifols
Device: Surgicel®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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 Soft Tissue Open Surgeries

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Percentage of Subjects Achieving Hemostasis Within 4 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.


Secondary Outcome Measures:
  • Time to Hemostasis (TTH) [ Time Frame: From start of treatment to the end of the 10-minute observational period ]
    TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.

  • Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart. [ Time Frame: From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment ]
  • Treatments Failures [ Time Frame: From start of treatment to time of completion of surgical closure. ]

    The following were considered treatment failures:

    Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure.



Enrollment: 327
Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrin Sealant (FS) 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).
Biological: Fibrin Sealant (FS) Grifols
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).
Active Comparator: Surgicel®
Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
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 Name: Oxidized regenerated cellulose hemostat

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) surgical procedure involving soft (non-parenchymous) tissue.
  • Target bleeding site is identified on soft tissue during urologic, gynecologic or general surgery procedures: 1) Simple or radical nephrectomies, 2) Total adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9) Mastopexies, and 10) Abdominoplasties.
  • A target bleeding site can be identified.
  • Target bleeding site has moderate bleeding according to the Investigator's judgment.

Exclusion Criteria:

  • Require thoracic, abdominal, retroperitoneal or pelvic surgery 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 FS 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 cut soft tissue surface identified as the target bleeding site prior to application of the study treatment.
  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: NCT01731938

  Show 25 Study Locations
Sponsors and Collaborators
Grifols Biologicals Inc.
Instituto Grifols, S.A.
  More Information

Responsible Party: Grifols Biologicals Inc.
ClinicalTrials.gov Identifier: NCT01731938     History of Changes
Other Study ID Numbers: IG1103
Study First Received: November 19, 2012
Results First Received: November 2, 2016
Last Updated: January 3, 2017

Keywords provided by Grifols Biologicals Inc.:
Fibrin Sealant
Soft tissue open surgery
Oxidized cellulose pads

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on March 30, 2017