Pradaxa Lawsuit: Venous occlusive intracranial disease is associated with oral contraceptive use the immediate post-partum period, and a wide range of hypercoagulable medical conditions. Significant cerebral venous thrombosis involves one or more of the major venous sinuses and typically results in parenchymal hemorrhage. By definition, the territories of the ischemic and hemorrhagic lesions are in a venous, rather than arterial, distribution. Involvement of the deep venous system (case study 3) carries a much worse prognosis than if only the superficial sinuses and/or cortical veins (1.20) are involved. Magnetic resonance venography (MRV) is commonly used to identify major venous sinus occlusions.
Pradaxa Lawsuit:Significant clinical deterioration associated with PH is known as ‘symptomatic hemorrhage, an important outcome measure in acute stroke treatment. One common definition for symptomatic hemorrhage is a clinical deterioration of >4 points on the National Institutes of Health Stroke Scale (NIHSS) associated with hemorrhage seen on CT scan. Various predictors for symptomatic hemorrhage include hyperglycemia, concurrent heparin use, the timing of successful recanalization, a history of diabetes and cardiac disease; leukoariosis, early signs of infarct on CT scans, and elevated pretreatment mean blood pressure. Neurosurgical evacuation typically is not a helpful treatment for symptomatic hemorrhage, because the lesion is frequently large and multifocal. Extra-ischemic hematomas are: located remotely from the initial ischemic stroke lesion; may be isolated or multifocal, with or without mass effect (1.17);23 and associated with concurrent coagulopathy and previously occult vasculopathies, such as CAA, microhemorrhages, or hypertensive vasculopathy. In the NINDS (National Institute of Neurological Disorders and Stroke) trial of IV t-PA for AIS, the incidence of extra-ischemic cerebral hematomas was 1.3%.
Pradaxa Lawsuit:The single mandated indication for neurosurgical decompression is cerebellar hemorrhage. Early craniotomy, prior to brainstem compression, is critical. The best surgical candidates are patients with an initial GCS <14 and hematoma volume >40 ml, while those with higher GCS and smaller lesions are likely to have a good outcome with conservative, non-surgical management. Neurosurgical evacuation of clot in primary hemispheric ICH has had mixed results in randomized and nonrandomized clinical trials. The leading study, I-STICH (International Surgical Trial in Intracerebral Haemorrhage), identified neutral outcomes for early evacuation. Nonetheless, a role for neurosurgical decompression to reduce clot size may exist in highly selected patients, particularly younger patients (e.g., <60 years old) who have cerebellar hemorrhage, treated with neurosurgery. Head CT scan shows a large, primary ICH based in the cerebellar vermis, causing effacement of the basal cisterns around the pons and early obstructive hydrocephalus, with markedly enlarged temporal horns (arrows) (A). The patient underwent emergent craniotomy over the next few hours, and subsequent CT scan the following day (B) shows recovery of basal cisterns, reduction in ventricular size, and a pocket of air in the left cerebellar hemisphere (arrowhead), with some edema in the left middle cerebellar peduncle. Note the craniotomy defect from the left suboccipital approach.
Pradaxa Lawsuit