Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
ConditionAnti Phospholipid Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking Union Medical College Hospital
About this trial
Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by thrombosis and pregnancy morbidity in patients with persistently positive antiphospholipid antibodies (aPLs). However, large-scale research on general population with persistent aPLs has been lacking. This project proposes to establish the first multicenter cohort of patients with persistently positive aPLs in China and conduct a comprehensive clinical phenotyping study. Based on traditional phenotypes of thrombotic and pregnancy events, the focus will be on extra-standard clinical phenotypes and prospective assessment of event risk and prognosis in aPL-positive population. A prospective analysis of extra-standard antibodies will also be conducted to recommend detection criteria for extra-standard antibody application in China and to assess their clinical significance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients refuse to participate;
Unable to be followed.
Trial population
All patients with the presense of one or more of the following aPLs can be included, after obtaining the written informed consent. The aPLs include: 1)IgG and/or IgM anticardiolipin antibodies (aCL) in moderate or high titer (\>40 GPL or MPL units, respectively, or a titer \>99th percentile for the testing laboratory), measured by a standardized enzyme-linked immunosorbent assay (ELISA). 2) IgG and/or IgM anti-beta2-glycoprotein (GP) I \>40 GPL or MPL units, respectively, or a titer \>99th percentile for the testing laboratory, measured by a standardized ELISA according to recommended procedures. 3) Lupus anticoagulant (LA) activity detected according to published guidelines.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Vascular thrombosis related to aPLs
Venous thrombosis, arterial thrombosis, microscopic thrombosis
Time frame
36 months2
Pregnancy morbidity related to aPLs
One or more unexplained deaths of a morphologically normal fetus at ≥10 weeks gestation, or one or more premature births of a morphologically normal neonate before 34 weeks gestation because of eclampsia, preeclampsia, or placental insufficiency, or three or more consecutive spontaneous pregnancy losses at \<10 weeks gestation, unexplained by chromosomal abnormalities or by maternal anatomic or hormonal causes.
Time frame
36 monthsSecondary outcomes
1
antiphospholipid antibody profile
IgG and/or IgM anticardiolipin (ACL) antibodies, IgG and/or IgM anti-beta2-glycoprotein (GP), Lupus anticoagulant (LA) activity, IgA ACL/anti-β2-GP I，anti-annexin 5 antibody, anti-protein C, anti-protein S, anti-vimentin/cardiolipin complex, and anti-lysobisphosphatidic acid (LBPA) et al.
Time frame
36 months2
Extra-criteria manifestations
Thrombocytopenia, haemolytic anemia, APS nephropathy, heart valve lesions, non-stroke CNS manifestations, skin changes (livedo reticularis, leg ulcers)
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov