As with other types of intracranial hematomas, the blood almost always must be removed surgically to reduce the pressure on the brain. The hematoma is evacuated through a burr hole or craniotomy. If transfer to a facility with neurosurgery is unavailable, prolonged trephination (drilling a hole into the skull) may be performed in the emergency department. Large hematomas and blood clots may require an open craniotomy.Medications may be given after surgery. They may include antiseizure medications and hyperosmotic agents to reduce brain swelling and intracranial pressure.It is extremely rare to not require surgery. If the volume of the epidural hematoma is less than 30 mL, the clot diameter less than 15 mm, a Glasgow Coma Score above 8, and no visible neurological symptoms, then it may be possible to treat it conservatively. A CT scan should be performed, and watchful waiting should be done, as the hematoma may suddenly expand. Prognosis
The prognosis is better if there was a lucid interval than if the person was comatose from the time of injury. Arterial epidural hematomas usually progress rapidly. However, venous epidural hematomas, caused by a dural sinus tear, are slower.Outcomes are worse if there is more than 50 mL of blood in the hematoma before surgery. Age, pupil abnormalities, and Glasgow Coma Scale score on arrival to the emergency department also influence the prognosis.
The committee felt the drug failed to show a favorable risk-benefit ratio and questioned the equipose of the trial design, which allowed control arm patients who used sorafenib to transition to tivozanib following progression disease but not those on the experimental arm using tivozanib to transition to sorafenib. The application was formally rejected by the FDA in June 2013, saying that approval would require additional clinical studies.In 2016, AVEO Oncology published data in conjunction with the ASCO meeting showing a geographical location effect on overall survival in the Phase III trial.In 2016, AVEO Oncology announced the start of a second Phase III clinical study in third line advanced RCC patients.In 2016, EUSA Pharma and AVEO Oncology announced that tivozanib had been submitted to the European Medicines Agency for review under the centralised procedure.In June 2017, the EMA Scientific Committee recommended tivozanib for approval in Europe, with approval expected in September.In August 2017, the European Commission (EC) formally approved tivozanib in Europe. References
External links
"Tivozanib". Drug Information Portal. U.S. National Library of Medicine.