Clinical trial NCT01754480: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parenchymous Tissue Surgical Bleeding
Keywords: Fibrin Sealant
Parenchymous tissue open surgery
Hepatic Resection
Oxidized cellulose pads
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 325
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
timeFrame: From start of treatment until 4 minutes after treatment start
Secondary outcomes:
measure: Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start
timeFrame: From start of treatment until 3 minutes after treatment start
measure: Time to Hemostasis
timeFrame: From start of treatment until 10 minutes after treatment start
measure: Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
timeFrame: From start of treatment until 10 minutes after treatment start
measure: Prevalence of Treatment Failures
timeFrame: From start of treatment until 10 minutes after treatment start
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: 224
state: California
city: Los Angeles
country: United States
facility: 214
state: California
city: New Haven
country: United States
facility: 213
state: Connecticut
city: Augusta
country: United States
facility: 223
state: Georgia
city: Chicago
country: United States
facility: 228
state: Illinois
city: Goshen
country: United States
facility: 227
state: Indiana
city: Louisville
country: United States
facility: 207
state: Kentucky
city: New Orleans
country: United States
facility: 220
state: Louisiana
city: Bethesda
country: United States
facility: 229
state: Maryland
city: Saint Louis
country: United States
facility: 201
state: Missouri
city: Las Vegas
country: United States
facility: 231
state: Nevada
city: Albany
country: United States
facility: 200
state: New York
city: New York
country: United States
facility: 211
state: New York
city: New York
country: United States
facility: 212
state: New York
city: Charlotte
country: United States
facility: 230
state: North Carolina
city: Cincinnati
country: United States
facility: 233
state: Ohio
city: Hershey
country: United States
facility: 400
state: Pennsylvania
city: Philadelphia
country: United States
facility: 218
state: Pennsylvania
city: Philadelphia
country: United States
facility: 204
state: Pennsylvania
city: Charleston
country: United States
facility: 205
state: South Carolina
city: Memphis
country: United States
facility: 217
state: Tennessee
city: Nashville
country: United States
facility: 206
state: Tennessee
city: Houston
country: United States
facility: 216, 219
state: Texas
city: Salt Lake City
country: United States
facility: 232
state: Utah
city: Charlottesville
country: United States
facility: 226
state: Virginia
city: Madison
country: United States
facility: 202
state: Wisconsin
city: Budapest
country: Hungary
facility: 602
city: Pécs
country: Hungary
facility: 600
city: Moscow
country: Russian Federation
facility: 640
city: Saint-Petersburg
country: Russian Federation
facility: 641
city: Belgrade
country: Serbia
facility: 621, 622, 623
city: Niš
country: Serbia
facility: 620, 625
city: Novi Sad
country: Serbia
facility: 624
Study officials:
References: