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

Sheba Medical Center

Status: Unknown

Conditions: Hemophilia C

Treatments: Drug: recombinant factor VIIa

Study type: Interventional

Funder types: Other

Identifiers

NCT01538160

SHEBA-11-8657-OS-CTIL

Details and patient eligibility

About

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.

Full description

Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with severe factor XI deficiency who will give informed consent to participate in the study

Exclusion criteria

• patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
• Patients who required aorto-coronary bypass or any vascular surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)