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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A male neonate [age at the time of reaction onset not clearly stated] developed worsening of oropharyngeal bleeding and intracranial haemorrhage during treatment with alteplase [Activase] for systemic thrombolysis of an occlusive aortic thrombus. Subsequently, he died.
The 5-day-old male neonate, who was born at 38th weeks of gestational age, presented for extracorporeal membrane oxygenation [ECMO) to treat his respiratory failure. His treatment at the birth hospital, was started with the initiation of positive pressure ventilation for tachypnoea a few hours after birth and then intubation and mechanical ventilation were performed. He was diagnosed with persistent pulmonary hypertension. Immediately before transfer, he developed pulmonary haemorrhage, which required exchange of...
- Onwubiko C, et al. Systemic thrombolysis of an occlusive aortic thrombus in a neonate on extracorporeal membrane oxygenation. American Surgeon 84: E372-E374, No. 9, 01 Sep 2018. Available from: URL: https://www.ingentaconnect.com/search?form_name=quicksearch&ie=%E0%A5%B0&option1=tka&value1=Systemic+thrombolysis+of+an+occlusive+aortic+thrombus+in+a+neonate+on+extracorporeal+membrane+oxygenation - USA