Hemophilia C
Conditions
Keywords
recombinant factor VIIa, factor XI deficiency
Brief 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.
Detailed 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.
Interventions
single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency | 1 week | End point to be assessed the degree of bleeding following major operation under rFVIIa |
Countries
Israel
Contacts
Primary ContactOphira Salomon, MD
Backup ContactUri Seligsohn, MD
Outcome results
None listed