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Fibrin Sealant Grifols · 4 trials · 4 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.
| 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. |
| 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. |
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 surgical bleeding. It is studied for vascular surgical bleeding, soft tissue surgical bleeding, parenchymous tissue surgical bleeding, and excessive bleeding during surgery. It is being developed by Grifols, S.A. (GRFS) and is currently in Phase 3 clinical development.
Fibrin Sealant Grifols is a monoclonal antibody modality. It is designed to act as a sealant to promote hemostasis during surgical procedures. The product is applied to bleeding sites to help achieve and maintain surgical hemostasis in various tissue types.
Fibrin Sealant Grifols is developed by Grifols, S.A., a biopharmaceutical company. The company's stock ticker is GRFS. Grifols is conducting Phase 3 clinical trials to evaluate the safety and efficacy of this fibrin sealant in surgical settings.
Fibrin Sealant Grifols is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. Multiple Phase 3 trials have been completed to assess its use as an adjunct to hemostasis during various types of surgery.
Fibrin Sealant Grifols has completed several Phase 3 trials. NCT01662856 evaluated its use in peripheral vascular surgery, NCT01731938 in soft tissue open surgeries, NCT01754480 in parenchymous tissue open surgeries, and NCT03461406 in pediatric participants undergoing surgery. All trials are completed.
Yes, Fibrin Sealant Grifols is also known as FS Grifols. Clinical trial titles refer to the product as both Fibrin Sealant Grifols and FS Grifols. These names refer to the same investigational fibrin sealant product developed by Grifols.