drugset / Trial / NCT01538160
A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
NaSingle-groupOpen-labelTreatment
Summary
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.
Timeline
- Start
- 2012-02
- Primary completion
- 2015-07
- Completion
- 2015-07
Publications
- Background Salomon et al presented at ASH 2008 entitled
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Factor VIIa | Protein / enzyme biologic | 20 ug/kg | — |
| Background | Tranexamic Acid | Small molecule | 4 g | — |