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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 case report, an 83-year-old woman and an 88-year-old woman were described, who developed active bleeding in the abdomen following anticoagulant treatment with enoxaparin sodium [routes not stated] for atrial fibrillation [outcomes of the reactions not stated].
The 83-year-old woman (clinical case 1): The woman presented to a hospital with asthenia, ageusia and hyporexia of 17 days of evolution. She was eventually diagnosed with COVID-19 pneumonia. She was therefore hospitalised, and she started receiving off-label therapy with lopinavir/ritonavir and hydroxychloroquine for COVID-19 pneumonia. Her medical history was significant for an ischaemic stroke in the middle cerebral artery 6 years previously and pacemaker carrier for tachycardia-bradycardia syndrome for 1 year. Also, she had been receiving anticoagulation with rivaroxaban for atrial fibrillation. At current admission, the anticoagulation treatment was switched from rivaroxaban to enoxaparin sodium [enoxaparin] 80 mg/12h. Twelve days following hospitalisation (initiation of enoxaparin sodium), while she was standing up to and was getting ready for her discharge, she experienced a feeling of non-specific light-headedness, and she fell on the floor, without losing her consciousness. Also, a poor peripheral perfusion and low blood pressure was noted. Blood tests were significant for a decrease in Hb (6.2 g/dL). A subsequent CT scan revealed an intra-abdominal pelvic haematoma secondary to an active bleeding from the left inferior epigastric artery. The anticoagulation therapy with enoxaparin sodium was determined to be a risk factor for active bleeding in the abdomen.
The 88-year-old woman (clinical case 2): The woman was admitted with dry cough in addition to few neurological symptoms. She was eventually diagnosed with COVID-19 pneumonia, for which she started receiving off-label therapy with hydroxychloroquine and azithromycin. Her medical history was significant for permanent atrial fibrillation, for which she had been receiving anticoagulation with acenocoumarol. Five days prior to the current presentation, she had got discharge from another hospital, where she had a fall. At the current presentation, her anticoagulation treatment was switched from acenocoumarol to enoxaparin sodium [enoxaparin] 60 mg/12h, and she was discharged after 24 hours. However, 6 days after the discharge (7 days after initiation of enoxaparin sodium), she presented to the emergency room with left costal pain, which she considered to have related to a fall during the previous hospitalisation. Saturation was noted to be 98%, and bibasal crackles were observed on auscultation. Analytically, she had a decreased level of Hb (9.5 g/dL). The Hb at previous hospitalisation was 11.4 g/dL. The Hb level decreased further to 6.9 mg/dL after 4 hours; however, the other blood counts were normal. She had altered values of glucose (131 mg/dL), creatine kinase (323 U/L), LDH (247 U/L), creatinine (1.2 mg/dL), sodium (128 mEq/L), D-dimer (1.25 µg/mL) and CRP (23 mg/L). Imaging of the thorax showed persistent bilateral infiltrates, without any rib fractures. A subsequent abdominal CT scan demonstrated a haematoma in the left lateral abdominal wall between the oblique muscles along with active bleeding. The anticoagulation therapy with enoxaparin sodium was determined to be a risk factor for active bleeding in the abdomen.