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Also known as Fibrin Sealant Grifols
FS 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...
FS Grifols is a fibrin sealant used as an adjunct to hemostasis to control bleeding at the target bleeding site during peripheral vascular surgery. It is a monoclonal antibody modality being developed by Grifols, S.A. for this surgical indication.
FS Grifols is being developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GRFS. The company is conducting clinical research on this fibrin sealant for use in peripheral vascular surgery.
FS Grifols is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed to evaluate its safety and efficacy as an adjunct to hemostasis.
FS Grifols has one completed Phase 2 clinical trial, registered as NCT00684047, titled "Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis." The trial enrolled 239 participants across Canada, Spain, and the United Kingdom.
Yes, FS Grifols is the same as fibrin sealant Grifols. The clinical trial NCT00684047 refers to the product as "Fibrin Sealant Grifols," and FS Grifols is the name used for this fibrin sealant product in development.