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

NCT01731938 | Completed Phase 3 Results

• 1 other identifier: IG1103
• Study Type: interventional
• Target: 327
• Locations: 3 countries
• Sites: 25

Brief Summary

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.

Conditions

Soft Tissue Surgical Bleeding

Keywords

Fibrin Sealant; Soft tissue open surgery; Oxidized cellulose pads

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving Hemostasis Within 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.

  From start of treatment until 4 minutes after treatment start

Secondary Outcomes (3)

• Time to Hemostasis (TTH)

  From start of treatment to the end of the 10-minute observational period

• 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.

  From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment

• Treatments Failures

  From start of treatment to time of completion of surgical closure.

Study Arms (2)

Fibrin Sealant (FS) Grifols

EXPERIMENTAL

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

Surgicel®

ACTIVE COMPARATOR

Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Device: Surgicel®

Interventions

Fibrin Sealant (FS) Grifols BIOLOGICAL

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).

Fibrin Sealant (FS) Grifols

Surgicel® DEVICE

Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Also known as: Oxidized regenerated cellulose hemostat

Surgicel®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grifols Biologicals, LLC: lead
• Instituto Grifols, S.A.: collaborator

Study Sites (25)

407

Florence, Alabama, 35630, United States

Location

320, 322, 323

Pasadena, California, 91105, United States

Location

404

Bridgeport, Connecticut, 06606, United States

Location

321

Boynton Beach, Florida, 33472, United States

Location

312

Rochester, Minnesota, 55905, United States

Location

300

St Louis, Missouri, 63110, United States

Location

327

Albany, New York, 12208, United States

Location

305

New York, New York, 10016, United States

Location

332

Poughkeepsie, New York, 12601, United States

Location

304

Winston-Salem, North Carolina, 27157, United States

Location

307

Pittsburgh, Pennsylvania, 15224, United States

Location

325

Charleston, South Carolina, 29425, United States

Location

331

Chattanooga, Tennessee, 37403, United States

Location

314

Memphis, Tennessee, 38613, United States

Location

402

Houston, Texas, 77024, United States

Location

316

Houston, Texas, 77030, United States

Location

405

Tacoma, Washington, 98431, United States

Location

702

Budapest, 1082, Hungary

Location

701

Debrecen, 4031, Hungary

Location

700

Debrecen, 4032, Hungary

Location

703

Debrecen, 4032, Hungary

Location

704

Győr, 9023, Hungary

Location

720, 722, 726, 723

Belgrade, 11000, Serbia

Location

725

Niš, 18000, Serbia

Location

721, 724

Novi Sad, 21000, Serbia

Location

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Henry Li, PhD, RAC
• Organization: Grifols Therapeutics, Inc.

Henry.Li@Grifols.com

1-919-316-6042

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Locations

US (17); HU (5); SE (3)