[Early termination of the multicentre randomised clinical trial to evaluate the benefit of testing for thrombophilia following a first venous thromboembolism: the NOSTRADAMUS study].
The NOSTRADAMUS study (ISRCTN07836779) was prematurely terminated due to low inclusion rates. There were several causes for this low inclusion: delay of approval by medical ethics committees, competition with industry-initiated intervention studies with a higher financial compensation, and the lack of study staff and allowance of expenses. We advise restraint with respect to testing for thrombophilia in patients with a first deep vein thrombosis or pulmonary embolism, as the benefit of this procedure has yet to be demonstrated.
Academisch Medisch Centrum/Universiteit van Amsterdam, afd. Vasculaire Geneeskunde, Meibergdreef 9, 1105 AZ Amsterdam. d.m.cohn@amc.uva.nl
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D000925:Anticoagulants / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D028744:Ethics Committees, Research / Q000592:standards*; D019317:Evidence-Based Medicine; D006801:Humans; D008403:Mass Screening; D009426:Netherlands; D011655:Pulmonary Embolism / Q000188:drug therapy / Q000209:etiology; D012106:Research / Q000191:economics*; D018570:Risk Assessment; D013923:Thromboembolism / Q000188:drug therapy / Q000209:etiology; D019851:Thrombophilia / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy / Q000209:etiology
D000925:Anticoagulants
Vroegtijdige beëindiging van het onderzoek naar het nut van trombofilietests bij een eerste veneuze trombo-embolie: het NOSTRADAMUS-onderzoek.