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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery
Ophira Salomon
Ramat Gan, Israel
Sheba Medical Center
Ramat Gan, Israel
Sheba Medical Center
Tel Hashomer, Ramat-Gan, Israel
Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency
End point to be assessed the degree of bleeding following major operation under rFVIIa
Time frame: 1 week
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