Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fibrin Sealant (FS) Grifols, FS Grifols
Fibrin Sealant Grifols · 5 trials · 5 indications
Hemostasis is defined as Grade 0 bleeding per 5-point validated bleeding severity scale (0=no bleeding and 4=Unidentified or inaccessible spurting or gush) at the target bleeding site (TBS) according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin.
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
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.
The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
| Arm | Type | Description |
|---|---|---|
| Fibrin Sealant Grifols | EXPERIMENTAL | Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder. |
| EVICEL | ACTIVE_COMPARATOR | Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically. |
| Surgicel® | ACTIVE_COMPARATOR | Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
| 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). |
| Manual Compression | ACTIVE_COMPARATOR | Direct manual compression of target bleeding site with gauze/laparotomy pads. |
| FS Grifols Preliminary Part (I) | EXPERIMENTAL | Open label administration of FS Grifols to all subjects |
| FS Grifols Primary Part (II) | EXPERIMENTAL | Single-blind, randomized (2:1) |
| Manual Compression Primary Part (II) | ACTIVE_COMPARATOR | Single-blind, randomized (2:1) |
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant Grifols | BIOLOGICAL | The FE Grifols solution was applied topically via drip or spray application. |
| EVICEL | BIOLOGICAL | The EVICEL solution was applied topically via drip or spray application. |
| 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. |
| 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). |
| Manual Compression | PROCEDURE | Direct manual compression of target bleeding site with gauze/laparotomy pads. |
| FS Grifols | BIOLOGICAL | Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I) |
Inclusion Criteria: Pre-operative: 1. Less than 18 years of age. 2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure. 3. Participant and/or participant's legal guardian is willing to give permission for the participant to...
Fibrin Sealant Grifols is used as an adjunct to hemostasis to control excessive bleeding during surgery. Its studied surgical settings include parenchymous tissue surgical bleeding, soft tissue surgical bleeding, and vascular surgical bleeding, including peripheral vascular surgery. It is also being studied in pediatric surgical participants.
Fibrin Sealant Grifols is developed by Grifols, S.A., which trades under the ticker GRFS. The product is named for the company, and Grifols is the sponsor of the clinical program evaluating it as a surgical hemostatic adjunct.
Fibrin Sealant Grifols is in Phase 3 development. Its Phase 3 program includes completed trials in parenchymous tissue, soft tissue, and vascular surgery, plus a completed pediatric study. It is an investigational product and is not described as FDA approved in the available program information.
The Phase 3 program includes NCT03461406 in pediatric surgery, NCT01754480 in parenchymous tissue open surgeries, NCT01731938 in soft tissue open surgeries, and NCT01662856 in peripheral vascular surgery. All four trials are completed, and the studies were conducted across sites in the United States, Europe, and Russia.
Yes. Fibrin Sealant (FS) Grifols is an alternative name for Fibrin Sealant Grifols, and the abbreviated form FS Grifols appears in the trial titles. All of these names refer to the same Grifols surgical hemostatic product.
The Fibrin Sealant Grifols Phase 3 trials enrolled 327 participants in the soft tissue surgery study, 325 in the parenchymous tissue study, 225 in the peripheral vascular surgery study, and 186 in the pediatric study. The trials were randomized and used active controls.