Clinical criteria | Â |
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 Vascular thrombosis | One or more episodes of arterial, venous or small vessel thrombosis in any tissue or organ (confirmed by objective validated criteria (imaging study or histopathology)) |
 Pregnancy complications | One or more unexplained deaths of a morphologically normal fetus ≥10th gestational week |
 | One or more premature births (≤34th gestational week) of a morphologically normal neonate because of eclampsia, severe pre-eclampsia or placental insufficiency |
 | Three or more unexplained consecutive spontaneous abortions ≤9th gestational week (maternal anatomic and hormonal abnormalities and chromosomal abnormalities excluded) |
Laboratory criteria | Â |
 Lupus anticoagulant present in plasma | Detected according to the guidelines of the International Society of Thrombosis and Haemostasis (Scientific subcommittee on lupus anticoagulant/phospholipid-dependent antibodies) |
 IgG and/or IgM anti-cardiolipin antibodies in serum of plasma | At medium/high titer (≥40 GPL or MPL or ≥99th percentile) measured by standard ELISA |
 IgG and/or IgM anti-β2 glycoprotein I antibodies in serum or plasma | Titer ≥99th percentile measured by standard ELISA, according to recommended procedures |