Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 6/23/2018 |
| Start Date: | April 7, 2018 |
| End Date: | July 2020 |
| Contact: | Brian T Jankowitz, MD |
| Email: | jankbt@upmc.edu |
| Phone: | 412-471-4772 |
ROSA Stereotactic Robot-assisted Intracerebral Hemorrhage Clot Evacuation
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.
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.
The introduction of the ROSA stereotactic robot offers an image guided stereotactic approach
with greater precision and accuracy than traditional frame-based and frameless methods. While
the ROSA has never been used for the placement of intra-hemorrhage catheters, prior
applications such as brain biopsies and abscess drainage represent similar surgical
procedures which require the same planning, precision, and surgical technique. At the very
least, ROSA offers an accurate image guided approach to deep lesions that should be
comparable to competitive image guided platforms. At best, ROSA offers superior trajectory
planning software, greater ease in planning multiple trajectories to large, irregular clots,
and the potential for robot aided navigation into and out of the hematoma which is the
greatest source of human error in these cases. For instance, the procedure often requires
advancement of a larger aspiration catheter, slow aspiration as the catheter is withdrawn,
and then re-advancement of a smaller catheter into the hematoma, which is left in place. The
ability to advance and remove catheters in a fixed trajectory with robotic assistance may
represent the greatest advantage of ROSA.
with greater precision and accuracy than traditional frame-based and frameless methods. While
the ROSA has never been used for the placement of intra-hemorrhage catheters, prior
applications such as brain biopsies and abscess drainage represent similar surgical
procedures which require the same planning, precision, and surgical technique. At the very
least, ROSA offers an accurate image guided approach to deep lesions that should be
comparable to competitive image guided platforms. At best, ROSA offers superior trajectory
planning software, greater ease in planning multiple trajectories to large, irregular clots,
and the potential for robot aided navigation into and out of the hematoma which is the
greatest source of human error in these cases. For instance, the procedure often requires
advancement of a larger aspiration catheter, slow aspiration as the catheter is withdrawn,
and then re-advancement of a smaller catheter into the hematoma, which is left in place. The
ability to advance and remove catheters in a fixed trajectory with robotic assistance may
represent the greatest advantage of ROSA.
Inclusion Criteria:
- Age 18-85
- Head CT demonstrates an acute, spontaneous, supratentorial, primary ICH
- ICH volume ≥30 cc
- Surgery initiated within 48 hours of hospital admission
Exclusion Criteria:
- 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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Brian T Jankowitz, MD
Phone: 412-647-4992
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