drugset / Trial / NCT01538160

A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery

NCT01538160

Unknown 15 enrolled Sheba Medical Center
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

EvaluationDrugModalityDoseRoute
Subject Recombinant Factor VIIa Protein / enzyme biologic 20 ug/kg
Background Tranexamic Acid Small molecule 4 g