Enoxaparin-sodium

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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

A case series described two men, aged 75−79 years, who developed iliopsoas haematoma during prophylactic treatment with enoxaparin-sodium [routes not stated].

Case 1: The 75-year-old man was admitted to a hospital in Italy with worsening pneumonia and loss of consciousness in March 2020. His medical history was significant for the chronic obstructive pulmonary disease, and he had been receiving treatment with clopidogrel for carotid atheromatous plaques and a previous ischaemic stroke. He tested positive for COVID-19. Therefore, he started receiving off label treatment with lopinavir/ritonavir and hydroxychloroquine for COVID-19. As per hospital protocol, additionally he started receiving prophylactic treatment with enoxaparin-sodium [enoxaparin] 4000IU two times a day, and clopidogrel was stopped. After 7 days of hospitalisation, he suffered a transient ischaemic attack and therefore, the dose of enoxaparin-sodium was increased to 6000IU two times a day. However, 10 days later, he developed abdominal pain. Subsequently, his CT scan showed evident thickening with signs of hyperaemia and oedematous imbibition, in both iliopsoas muscles, with haematoma axial dimensions of 52.6mm on the right and 40.5mm on the left. His prothrombin time, partial thromboplastin time and fibrinogen were normal; however, moderate thrombocytopenia was noted before the onset of haematoma. Also, his haemoglobin was decreased by 2 g/dL. The platelet count normalised 4 days later. Then, the dose of enoxaparin-sodium was reduced to 4000IU two times a day. Thereafter, he received blood transfusions. After stabilisation of haemoglobin, the dose of enoxaparin-sodium was increased to 5000IU two times a day. Following 27 days, his hematoma was completely reabsorbed. He was discharged from the hospital after day 49, on enoxaparin-sodium for a month, followed by re-initiation of clopidogrel.

Case 2: The 79-year-old man was admitted to hospital in Italy due to respiratory failure secondary to COVID-19 in year 2020. At the time of admission, he suffered from hypertension and was not on any antithrombotic treatment prior to hospitalisation. His medical history was significant for obesity. Following the admission, he started receiving off label treatment with baricitinib and hydroxychloroquine for COVID-19. Additionally, he started receiving prophylactic treatment with enoxaparin-sodium [enoxaparin] 6000IU two times a day. However, 2 weeks after admission, he showed a unprovoked right iliopsoas haematoma. Therefore, the dose of enoxaparin-sodium was reduced to 5000IU twice daily. The haematoma was completely reabsorbed following 21 days. He was discharged from the hospital after 57 days of hospitalisation. He was advised to continue enoxaparin-sodium for a month.