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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03386656 | Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery | PHASE3 | COMPLETED | 150 | — | — | Nov 28, 2017 | May 8, 2019 | Jan 18, 2020 | 1 | Spain |
Total blood loss greater than 245 ml
| Arm | Type | Description |
|---|---|---|
| Amchafibrin | EXPERIMENTAL | Estimated total blood loss, measured using the formula described by Nadler. A difference in estimated blood loss greater than or equal to 245 ml will be considered clinically relevant. |
| Saline Solution 0,9%. | PLACEBO_COMPARATOR | Comparator of tranexamic acid |
| Name | Type | Description |
|---|---|---|
| Amchafibrin | DRUG | Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. |
| Saline Solution | OTHER | Placebo |
Inclusion Criteria: * Patients of both sexes, in the age group: ≥18 and ≤80 years. * Patients diagnosed with confirmation of severe knee osteoarthritis according to Kellgren criteria (equal or greater than 2) and EVA greater than 7, who will be subjected to knee arthroplasty surgery. * Patients sig...