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

NCT ID: NCT01731938

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Fibrin Sealant (FS) Grifols

Intervention Type: 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).

Surgicel®

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

Group Type: ACTIVE_COMPARATOR

Surgicel®

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: BIOLOGICAL

Surgicel®

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

Intervention Type: DEVICE

Other Intervention Names

Oxidized regenerated cellulose hemostat

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) 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: collaborator

Grifols Biologicals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

407

Florence, Alabama, United States

320, 322, 323

Pasadena, California, United States

404

Bridgeport, Connecticut, United States

321

Boynton Beach, Florida, United States

312

Rochester, Minnesota, United States

300

St Louis, Missouri, United States

327

Albany, New York, United States

305

New York, New York, United States

332

Poughkeepsie, New York, United States

304

Winston-Salem, North Carolina, United States

307

Pittsburgh, Pennsylvania, United States

325

Charleston, South Carolina, United States

331

Chattanooga, Tennessee, United States

314

Memphis, Tennessee, United States

402

Houston, Texas, United States

316

Houston, Texas, United States

405

Tacoma, Washington, United States

702

Budapest, , Hungary

701

Debrecen, , Hungary

700

Debrecen, , Hungary

703

Debrecen, , Hungary

704

Győr, , Hungary

720, 722, 726, 723

Belgrade, , Serbia

725

Niš, , Serbia

721, 724

Novi Sad, , Serbia

Countries

United States; Hungary; Serbia

Other Identifiers

IG1103

Identifier Type: -

Identifier Source: org_study_id