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Lack of effect of a low-molecular-weight heparin (nadroparin) on mortality in bedridden medical in-patients: a prospective randomised double-blind study

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Abstract

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].

Conclusion

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.

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Acknowledgements

Funding: This study was supported by a grant for Independent Research from Sanofi-Choay.

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Authors and Affiliations

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Corresponding author

Correspondence to I. Mahé.

Additional information

The full list of investigators involved in the CY 216 study are given in Appendix A.

Appendices

Appendix A

Investigators

Paris (France): Lariboisière (Pr Segrestaa, Pr Bergmann), Cité Universitaire (Dr Abiven, Dr Tirouvanziam), Nice (France) (Pr Babeau, Dr Pras), Toulon (Pr Chagnon, Dr Auzanneau), Bordeaux (France): St André (Pr Blanchot, Dr Le Metayer), St André (Pr Paccalin, Dr Dabadie), Lille (France) (Pr Choteau, Dr Leduc), Paris (France): Rothschild (Pr Dry, Pr Pradalier), Caen (France) (Pr Letellier, Dr Agron), Bruges (Belgium) (Dr van Couter), Bruxelles (Belgium) (Pr Fondu, Dr Rauis), Liège (Belgium) (Dr David, Dr Closon), Montpellier (France): St Eloi (Pr Janbon, Dr Rossi), Chauliac (Pr Bertrand, Dr Serveaux), Strasbourg (France): Hautepierre (Pr Imler, Dr Cherfan), Hospices civils (Pr Stork, Dr Villard), Kremlin Bicêtre (France) (Pr Caquet, Pr Passeron), Bordeaux (France): Pellegrin (Pr Lacut, Dr Dupon), Pellegrin (Pr Aubertin), Paris (France): Cochin (Pr Detilleux), Nantes (France) (Pr Cottin, Dr Ponge), Grenoble (France) (Pr Massot, Dr Leduc), Nancy (France): Brabois (Pr Cuny, Dr Preiss), Hôpital central (Pr Schmitt, Dr de Korwin), Tours (France) (Pr Guilmot, Dr Lasfargues), Dijon (France) (Pr Martin, Dr Lorcerie), Amiens (France) (Pr Baillet, Dr Smail), Bordeaux (France): St André (Pr Serie), Angers (France) (Dr Fressinaud, Dr Suraniti), Milan (Italia) (Pr Lucchelli, Dr Morgutti), Padova (Italia) (Pr Ruol, Dr Prandoni), La Coruna (Spana) (Dr Pedreira), Bilbao (Spana) (Dr Aguirre)

Appendix B

Table 3 Consort statement

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Mahé, I., Bergmann, J.F., d’Azémar, P. et al. Lack of effect of a low-molecular-weight heparin (nadroparin) on mortality in bedridden medical in-patients: a prospective randomised double-blind study. Eur J Clin Pharmacol 61, 347–351 (2005). https://doi.org/10.1007/s00228-005-0944-3

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  • DOI: https://doi.org/10.1007/s00228-005-0944-3

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