Parenchymous Tissue Surgical Bleeding Clinical Trial
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
This study is designed to assess the safety and efficacy of fibrin sealant (FS) 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 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.
| Status | Completed |
| Enrollment | 325 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 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 resection surface of the liver prior to application of study treatment. - Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary haemostatic treatment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hungary | 602 | Budapest | |
| Hungary | 600 | Pécs | |
| Russian Federation | 640 | Moscow | |
| Russian Federation | 641 | Saint-Petersburg | |
| Serbia | 621, 622, 623 | Beograd | |
| Serbia | 620, 625 | Niš | |
| Serbia | 624 | Novi Sad | |
| United States | 200 | Albany | New York |
| United States | 223 | Augusta | Georgia |
| United States | 229 | Bethesda | Maryland |
| United States | 205 | Charleston | South Carolina |
| United States | 230 | Charlotte | North Carolina |
| United States | 226 | Charlottesville | Virginia |
| United States | 228 | Chicago | Illinois |
| United States | 233 | Cincinnati | Ohio |
| United States | 227 | Goshen | Indiana |
| United States | 400 | Hershey | Pennsylvania |
| United States | 216, 219 | Houston | Texas |
| United States | 231 | Las Vegas | Nevada |
| United States | 224 | Loma Linda | California |
| United States | 214 | Los Angeles | California |
| United States | 207 | Louisville | Kentucky |
| United States | 202 | Madison | Wisconsin |
| United States | 217 | Memphis | Tennessee |
| United States | 206 | Nashville | Tennessee |
| United States | 213 | New Haven | Connecticut |
| United States | 220 | New Orleans | Louisiana |
| United States | 211 | New York | New York |
| United States | 212 | New York | New York |
| United States | 204 | Philadelphia | Pennsylvania |
| United States | 218 | Philadelphia | Pennsylvania |
| United States | 201 | Saint Louis | Missouri |
| United States | 232 | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Grifols, S.A. |
United States, Hungary, Russian Federation, Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects achieving hemostasis within four 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 | No |