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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a retrospective, controlled study of 308 patients with coronavirus disease 2019 (COVID-19) admitted to hospital in Italy and treated with thromboprophylaxis, 8 patients [ages and sexes not stated] were described, who developed major or clinically relevant bleeding complications during standard thromboprophylactic treatment with enoxaparin-sodium or fondaparinux-sodium [routes, doses and outcome of ADRs not stated].
The patients, who were admitted with non-critically ill COVID-19, started receiving standard thromboprophylactic treatment with enoxaparin-sodium [enoxaparin] once daily (n=1) and fondaparinux-sodium [fondaparinux] once daily. Concomitantly, they were treated with unspecified pharmacological treatment for the infectious disease. However, 8−21 days after initiation of thromboprophylactic treatment, they developed bleeding complications. One patient developed major gastrointestinal bleeding secondary to enoxaparin-sodium (n=1), and 7 patients developed major retroperitoneal bleeding (n=2), major gastrointestinal bleeding (n=2) and clinically relevant non major bleeding in the form of epistaxis (n=3) secondary to fondaparinux-sodium.
Therefore, all the patients discontinued the thromboprophylactic therapy.
Reference
- Prandoni P, et al. The hazard of fondaparinux in non-critically ill patients with COVID-19: Retrospective controlled study versus enoxaparin. Thrombosis Research 196: 395-397, Dec 2020. Available from: URL: 10.1016/j.thromres.2020.09.024 [DOI] [PMC free article] [PubMed]