Clinical trial NCT01731938: Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft 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 Soft Tissue Open Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Soft Tissue Surgical Bleeding
Keywords: Fibrin Sealant
Soft tissue open surgery
Oxidized cellulose pads
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
Collaborators: name: Instituto Grifols, S.A.
First posted: 2012-11-22
Enrollment: 327
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 (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.


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.

Primary outcomes:
measure: Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start
timeFrame: From start of treatment until 4 minutes after treatment start
Secondary outcomes:
measure: Time to Hemostasis (TTH)
timeFrame: From start of treatment to the end of the 10-minute observational period
measure: 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.
timeFrame: From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment
measure: Treatments Failures
timeFrame: From start of treatment to time of completion of surgical closure.
Other outcomes:
Locations:
city: Florence
country: United States
facility: 407
state: Alabama
city: Pasadena
country: United States
facility: 320, 322, 323
state: California
city: Bridgeport
country: United States
facility: 404
state: Connecticut
city: Boynton Beach
country: United States
facility: 321
state: Florida
city: Rochester
country: United States
facility: 312
state: Minnesota
city: Saint Louis
country: United States
facility: 300
state: Missouri
city: Albany
country: United States
facility: 327
state: New York
city: New York
country: United States
facility: 305
state: New York
city: Poughkeepsie
country: United States
facility: 332
state: New York
city: Winston Salem
country: United States
facility: 304
state: North Carolina
city: Pittsburg
country: United States
facility: 307
state: Pennsylvania
city: Charleston
country: United States
facility: 325
state: South Carolina
city: Chattanooga
country: United States
facility: 331
state: Tennessee
city: Memphis
country: United States
facility: 314
state: Tennessee
city: Houston
country: United States
facility: 402
state: Texas
city: Houston
country: United States
facility: 316
state: Texas
city: Tacoma
country: United States
facility: 405
state: Washington
city: Budapest
country: Hungary
facility: 702
city: Debrecen
country: Hungary
facility: 701
city: Debrecen
country: Hungary
facility: 700
city: Debrecen
country: Hungary
facility: 703
city: Győr
country: Hungary
facility: 704
city: Beograd
country: Serbia
facility: 720, 722, 726, 723
city: Niš
country: Serbia
facility: 725
city: Novi Sad
country: Serbia
facility: 721, 724
Study officials:
References: