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

Phase 3

Completed

Conditions: Parenchymous Tissue Surgical Bleeding

Interventions: Device: Surgicel®
Biological: Fibrin Sealant Grifols

Registration Number: NCT01754480

Lead Sponsor: Instituto Grifols, S.A.

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 325

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgicel®	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Fibrin Sealant Grifols	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).

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start	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	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	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	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.

Trial Locations

Locations (33): 213
🇺🇸
New Haven, Connecticut, United States
206
🇺🇸
Nashville, Tennessee, United States
640
🇷🇺
Moscow, Russian Federation
621, 622, 623
🇷🇸
Belgrade, Serbia
217
🇺🇸
Memphis, Tennessee, United States
205
🇺🇸
Charleston, South Carolina, United States
224
🇺🇸
Loma Linda, California, United States
218
🇺🇸
Philadelphia, Pennsylvania, United States
229
🇺🇸
Bethesda, Maryland, United States
202
🇺🇸
Madison, Wisconsin, United States
212
🇺🇸
New York, New York, United States
223
🇺🇸
Augusta, Georgia, United States
228
🇺🇸
Chicago, Illinois, United States
227
🇺🇸
Goshen, Indiana, United States
207
🇺🇸
Louisville, Kentucky, United States
230
🇺🇸
Charlotte, North Carolina, United States
400
🇺🇸
Hershey, Pennsylvania, United States
200
🇺🇸
Albany, New York, United States
220
🇺🇸
New Orleans, Louisiana, United States
231
🇺🇸
Las Vegas, Nevada, United States
201
🇺🇸
Saint Louis, Missouri, United States
233
🇺🇸
Cincinnati, Ohio, United States
204
🇺🇸
Philadelphia, Pennsylvania, United States
600
🇭🇺
Pécs, Hungary
216, 219
🇺🇸
Houston, Texas, United States
602
🇭🇺
Budapest, Hungary
620, 625
🇷🇸
Niš, Serbia
624
🇷🇸
Novi Sad, Serbia
211
🇺🇸
New York, New York, United States
226
🇺🇸
Charlottesville, Virginia, United States
214
🇺🇸
Los Angeles, California, United States
232
🇺🇸
Salt Lake City, Utah, United States
641
🇷🇺
Saint-Petersburg, Russian Federation