Lack of effect of a low-molecular-weight heparin (nadroparin) on mortality in bedridden medical in-patients: a prospective randomised double-blind study.
BACKGROUND
Hospitalised medical patients are at significant risk of venous thromboembolic disease through fatal pulmonary embolism; low-molecular-weight heparins have been proved efficient in preventing deep venous thrombosis in surgical and medical patients, but their effect on mortality in bedridden medical patients remains unknown.


METHODS
In a multi-centre, randomised, double-blind, placebo-controlled study, 2,474 consecutive patients aged over 40 years admitted to internal medicine departments in the last 24 h and unable to move alone were randomised to receive 0.3 ml nadroparin (7,500 anti-Xa units) or placebo for up to 21 days. The primary end-point was overall mortality at day 21.


RESULTS
There were no significant differences between the patients' characteristics. Overall mortality between the two groups was not statistically different [10.08% (124 of 1,230) versus 10.29% (128 of 1,244), respectively, in the nadroparin and in the placebo groups; relative risk reduction 0.02, CI (-0.27, +0.25), P=0.89]. An autopsy was performed in 123 of the 252 patients who died (49%). Pulmonary embolism was discovered at autopsy in 10 of 63 patients in the nadroparin group and in 17 of 60 in the placebo group [relative risk reduction 0.38, CI (-0.27, +0.70), P=0.13].


CONCLUSIONS
Nadroparin does not have a significant effect on mortality in bedridden medical patients, based on the study results. The study provides no data suggesting that low-molecular-weight heparins might reduce the incidence of thromboembolic in-patients hospitalised for an acute medical disease.
Mahé
I
I
Service Médecine A, AP-HP, Hôpital Lariboisière, 2, rue Ambroise Paré, 75010, Paris, France. isabelle.mahe@lrb.ap-hop-paris.fr
Bergmann
J F
JF
d'Azémar
P
P
Vaissie
J J
JJ
Caulin
C
C
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D001344:Autopsy; D004311:Double-Blind Method; D005260:Female; D006761:Hospitals; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017762:Nadroparin / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D016019:Survival Analysis; D013923:Thromboembolism / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*
D000925:Anticoagulants; D017762:Nadroparin