Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation
Withdrawn before enrolling · Not applicable
Conditions studied: Intracerebral Hematoma
In brief
Non-traumatic intracerebral hemorrhage (ICH) affects approximately 100,000 Americans yearly. Up to 30-50% of ICH is fatal, and those patients who survive are often left with significant neurologic dysfunction. In the past, medical management (e.g., control of hypertension, reversal of antiplatelet or anticoagulants) had been the most effective treatment for these patients, given the morbidity and mortality associated with open surgical treatment for evacuation of ICH. However, recent trials have demonstrated that minimally invasive stereotactic neurosurgical procedures to evacuate ICH are safe and result in improved outcomes for these patients. Initial attempts to evaluate the efficacy of surgical evacuation of ICH found no significant difference between medical management and standard craniotomy for surgical evacuation. Indeed, open surgery was often discouraged for these patients due to the significant morbidity and mortality associated with the surgical procedure itself. However, research has demonstrated that minimally invasive, image guided stereotactic frame-based and frameless methods are effective and safe for the placement of catheters for clot aspiration and fibrinolytic therapy of ICH in the basal ganglia and other deep seated regions. Larger randomized controlled trials have demonstrated that these minimally invasive approaches also offer clinical benefit for these patients.
Key facts
- Study ID
- NCT03414307
- Run by
- Zimmer Biomet
- People needed
- 0
- Starts
- 2020-09-30
- Expected to finish
- 2020-09-30
- Last updated by the study team
- 2021-07-23
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-85
- Head CT demonstrates an acute, spontaneous, supratentorial, primary ICH
- ICH volume ≥30 cc
- Surgery initiated within 48 hours of hospital admission
You may not qualify if…
- Pregnancy at the time of surgery
- Underlying vascular lesion defined as causative source of ICH
- Irreversible coagulopathy
- Profound neurological deficit defined as fixed/dilated pupils, bilateral extensor motor posturing
- Infratentorial or brainstem ICH
- Known life expectancy <6 months
Where it is running
- UPMC Stroke Institute — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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