Nadroparin calcium

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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 report described two women aged 76−85 years; they developed spontaneous retroperitoneal bleeding during thrombosis prophylaxis with nadroparin calcium.

Case 1: An 85-year-old woman, who had multiple morbidities, was hospitalised due to left hip contusion after a fall. After 1 week of hospitalisation, she tested positive for SARS-CoV-2 infection. She started receiving thrombosis prophylaxis with SC nadroparin calcium [Fraxiparine] 9800 IU/mL, 0.4mL every 12 hours. However, on day 6 after testing positive for for SARS-CoV-2 infection, she developed deep vein thrombosis of her left lower leg vasculature. Hence, the dose of nadroparin calcium was adjusted to 0.6mL after 12 hours. However, on day 13 after testing positive for for SARS-CoV-2 infection, she suddenly developed hypotension, accompanied by a decrease in haemoglobin (from 99 g/L to 69 g/L over 6 hours). She felt weak and reported pain in her left hip. CT scan revealed a large haematoma in the left retroperitoneum and iliopsoas, with a small active leak of contrast medium in the venous phase. She was administered crystalloid solutions and erythrocyte concentrates, after which her circulation stabilised. Nadroparin calcium was discontinued, and she received empirical antimicrobial prophylaxis with cephalosporin. However, the following morning, she developed hypotension again, accompanied by a further decrease in haemoglobin (from 101 g/L to 77 g/L during the night), which necessitated catecholamine support. Emergency surgery was scheduled, and approximately 1L haematoma was evacuated. Several small sources of bleeding from her left pelvic vein area were treated. Retroperitoneal drainage was introduced. After the procedure, her condition remained critical. In spite of comprehensive resuscitation care, the circulatory instability progressed due to circulatory shock, lactic acidosis and renal failure. She passed away the following morning.

Case 2: A 76-year-old woman, who had multiple morbidities, was hospitalised due respiratory failure secondary to COVID-19 infection. She received empirical therapy with clarithromycin and unspecified cephalosporins due to the suspicion of bacterial superinfection, alongside unspecified concomitant corticosteroid therapy and thrombosis prophylaxis with SC nadroparin calcium 9800 IU/mL, 0.3mL after 12 hours. The following day, remdesivir was initiated. Later, the dose of nadroparin calcium was adjusted to 0.4mL every 12 hours. On day 6 of hospitalisation, she suddenly developed dyspnoea in the morning, accompanied by hypotension and pain in the right half of the abdomen. Laboratory tests revealed a drop in haemoglobin (from 97 g/L to 52 g/L within 48 hours). She received crystalloids and erythrocyte concentrates, resulting in stabilisation of her circulation. CT scan of the abdomen revealed massive bleeding into the retroperitoneum on the right. Five hours after a conservative procedure, follow-up CT scan showed progression of retroperitoneal haematoma with a leak of contrast agent into the retroperitoneum at the L2 vertebra level. The lumbar artery was suspected to have been a source of bleeding. Another leak was apparent at the level of the large pelvis. Surgery was indicated, and about 1.5–2L of mixed blood was aspirated. Numerous small sources were treated; retroperitoneal tamponade was kept and drainage was performed. The anaemia persisted during the postoperative phase, for which she received numerous transfusion preparations, including erythtrocytic masses, blood plasma and platelet concentrates. Two days later, the retroperitoneal tamponade was removed during the planned revision, at which time, only a few small sources of bleeding were apparent, which were treated. Additionally, a haemostypic material with good effect was used. Over the following days, in spite of a successful resolution of bleeding complications, her general condition deteriorated, and she developed anuric renal failure. She passed away on day 4 after the removal of the retroperitoneal tamponade.