Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03461406 | A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants | PHASE3 | COMPLETED | 186 | — | — | Jan 18, 2019 | May 20, 2022 | Apr 14, 2023 | 40 | United States, Bulgaria +8 |
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.
| 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. |
| 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. |
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...