Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto Grifols, S.A. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin Sealant (FS) Grifols | Experimental | 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). |
|
| Surgicel® | Active Comparator | Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Sealant (FS) Grifols | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Hemostasis Within 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis (TTH) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 407 | Florence | Alabama | 35630 | United States | ||
| 320, 322, 323 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Preliminary Part I |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Surgicel® | Device | Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice. |
|
|
| From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment |
| Treatments Failures | 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. |
| Pasadena |
| California |
| 91105 |
| United States |
| 404 | Bridgeport | Connecticut | 06606 | United States |
| 321 | Boynton Beach | Florida | 33472 | United States |
| 312 | Rochester | Minnesota | 55905 | United States |
| 300 | St Louis | Missouri | 63110 | United States |
| 327 | Albany | New York | 12208 | United States |
| 305 | New York | New York | 10016 | United States |
| 332 | Poughkeepsie | New York | 12601 | United States |
| 304 | Winston-Salem | North Carolina | 27157 | United States |
| 307 | Pittsburgh | Pennsylvania | 15224 | United States |
| 325 | Charleston | South Carolina | 29425 | United States |
| 331 | Chattanooga | Tennessee | 37403 | United States |
| 314 | Memphis | Tennessee | 38613 | United States |
| 402 | Houston | Texas | 77024 | United States |
| 316 | Houston | Texas | 77030 | United States |
| 405 | Tacoma | Washington | 98431 | United States |
| 702 | Budapest | 1082 | Hungary |
| 701 | Debrecen | 4031 | Hungary |
| 700 | Debrecen | 4032 | Hungary |
| 703 | Debrecen | 4032 | Hungary |
| 704 | Győr | 9023 | Hungary |
| 720, 722, 726, 723 | Belgrade | 11000 | Serbia |
| 725 | Niš | 18000 | Serbia |
| 721, 724 | Novi Sad | 21000 | Serbia |
| FG001 | Surgicel® | Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Primary Part II |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fibrin Sealant (FS) Grifols Part I | 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). |
| BG001 | Surgicel® Part I | Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice. |
| BG002 | Fibrin Sealant (FS) Grifols Part II | 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). |
| BG003 | Surgicel® Part II | Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving Hemostasis Within 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. | Posted | Number | percentage of participants | From start of treatment until 4 minutes after treatment start |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Hemostasis (TTH) | 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. | Posted | Mean | Standard Error | minutes | From start of treatment to the end of the 10-minute observational period |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | percentage of subjects | From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Treatments Failures | 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. | Posted | Number | percentage of subjects | From start of treatment to time of completion of surgical closure. |
|
6 months
Adverse event data is based on the number of subjects who received study drug (safety population) in Preliminary Part (I) and Primary Part (II) of the study; 169 subjects in the FS Grifols group and 158 subjects in the Surgicel group. Two subjects who were randomized to the Surgicel treatment group received FS Grifols in error and are included in the FS Grifols treatment group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 17 | 169 | 149 | 169 | ||
| EG001 | Surgicel® | Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice. | 18 | 158 | 139 | 158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Mental status change | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Cervicitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
Site may publish results from the study, after providing Sponsor at least thirty days' notice prior to submitting a manuscript or other materials related to the study to any outside party. At Sponsor's request, the site will remove any confidential information (other than study results), and incorporate all reasonable comments by Sponsor, or delay publication or presentation for a period of up to 120 days to allow Sponsor to protect its interests in any Sponsor's Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henry Li, PhD, RAC | Grifols Therapeutics, Inc. | 1-919-316-6042 | Henry.Li@Grifols.com |
| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Death |
|
| Missed Week 6 visit |
|
| Between 18 and 64 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Not Specified |
|
|
|
|
|