- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731938
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Budapest, Hungary, 1082
- 702
-
Debrecen, Hungary, 4031
- 701
-
Debrecen, Hungary, 4032
- 700
-
Debrecen, Hungary, 4032
- 703
-
Győr, Hungary, 9023
- 704
-
-
-
-
-
Beograd, Serbia, 11000
- 720, 722, 726, 723
-
Niš, Serbia, 18000
- 725
-
Novi Sad, Serbia, 21000
- 721, 724
-
-
-
-
Alabama
-
Florence, Alabama, United States, 35630
- 407
-
-
California
-
Pasadena, California, United States, 91105
- 320, 322, 323
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06606
- 404
-
-
Florida
-
Boynton Beach, Florida, United States, 33472
- 321
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- 312
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- 300
-
-
New York
-
Albany, New York, United States, 12208
- 327
-
New York, New York, United States, 10016
- 305
-
Poughkeepsie, New York, United States, 12601
- 332
-
-
North Carolina
-
Winston Salem, North Carolina, United States, 27157
- 304
-
-
Pennsylvania
-
Pittsburg, Pennsylvania, United States, 15224
- 307
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- 325
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- 331
-
Memphis, Tennessee, United States, 38613
- 314
-
-
Texas
-
Houston, Texas, United States, 77024
- 402
-
Houston, Texas, United States, 77030
- 316
-
-
Washington
-
Tacoma, Washington, United States, 98431
- 405
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Surgicel®
Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
|
Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
Other Names:
|
Experimental: 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start
Time Frame: From start of treatment until 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Hemostasis (TTH)
Time Frame: From start of treatment to the end of the 10-minute observational period
|
TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.
|
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.
Time Frame: From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment
|
From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment
|
|
Treatments Failures
Time Frame: From start of treatment to time of completion of surgical closure.
|
The following were considered treatment failures: Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure. |
From start of treatment to time of completion of surgical closure.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IG1103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Soft Tissue Surgical Bleeding
-
Ethicon, Inc.CompletedHemorrhage | Soft Tissue Bleeding | Hepatic Parenchyma BleedingUnited Kingdom, Belgium
-
Ethicon, Inc.CompletedSoft Tissue BleedingNew Zealand, United Kingdom, Australia, Germany
-
Ethicon, Inc.CompletedHemorrhage | Soft Tissue BleedingBelgium, Canada, United Kingdom
-
Ethicon, Inc.CompletedHemorrhage | Soft Tissue BleedingUnited States
-
Instituto Grifols, S.A.CompletedSafety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open SurgeriesParenchymous Tissue Surgical BleedingUnited States, Hungary, Russian Federation, Serbia
-
University of Roma La SapienzaCompletedWound Heal | Wound Surgical | Oral Soft Tissue ConditionsItaly
-
Dilon Technologies Inc.Syneos HealthCompleted
-
MallinckrodtTerminated
-
University of Roma La SapienzaCompletedWound Heal | Wound Surgical | Oral Soft Tissue Conditions | Hyaluronic AcidItaly
-
University of Roma La SapienzaCompletedWound Heal | Wound Surgical | Oral Soft Tissue Conditions | Chlorhexidine Adverse ReactionItaly
Clinical Trials on Surgicel®
-
Cairo UniversityUnknownEndometrial HyperplasiaEgypt
-
Aesculap AGCompletedPeripheral Vascular Diseases | HemostasisGermany
-
GATT Technologies BVRecruitingLiver Diseases | Gallbladder Diseases | Intraoperative Bleeding | Hemorrhage, SurgicalUnited States
-
TakedaBaxter Healthcare CorporationCompleted
-
China Medical University, ChinaCompleted
-
TakedaCompleted
-
Fudan UniversityUnknown
-
Soonchunhyang University HospitalUnknownNon-variceal Upper Gastrointestinal BleedingKorea, Republic of
-
National Taiwan University HospitalUnknownPancreatic FistulaTaiwan