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The primary objective of this study is to determine the effectiveness of the NICO BrainPathâ„¢ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve <15 ml residual hematoma volume following surgery.
Additionally, the study aims to compare the mortality and complication rate of patients who undergo minimally invasive, navigation guided endoport based evacuation of intracerebral hematoma with NICO BrainPathâ„¢ System as compared to non-operative, supportive standard of care.
The study is a prospective, non-randomized cohort study. 50 patients will be enrolled in Group A (NICO BrainPathâ„¢ system) and 50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care from Epic). 50 patients will undergo minimally invasive, navigation guided endport based evacuation of intracerebral hematoma with NICO BrainPathâ„¢ System. The patient population receiving non-operative supportive care will be matched to the surgical patients based on age, gender, and location of hemorrhage.
Approximately 100 patients will participate in this study. Patients with significant intraparenchymal hemorrhage who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for eligibility.
A repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH will determine eligibility in the trial. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPathâ„¢ system.
At baseline, the Glasgow Coma Scale (GCS) and the Modified Rankin Score (mRS) will be captured, along with baseline demographics. The GCS and mRS will be recorded at 1-, 3, and 6-month post-operatively. A follow-up CT will be captured at 3 months. Mortality and adverse events will be reviewed at each timepoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NICO BrainPathâ„¢ Patients | 50 patients will be enrolled in Group A NICO BrainPathâ„¢ system. The NICO BrainPathâ„¢ System has been proposed to reduce high morbidity and mortality associated with ICH through minimally invasive clot evacuation. Previous, single-center trials concluded evacuation of ICH using the BrainPathâ„¢ system as being safe and effective. Additionally, previous studies concluded that lesser ICH removal was correlated with mortality benefit and that the NICO BrainPathâ„¢ system approach was shown to be safe and effective with a high rate of clot evacuation and functional independence. This system warrants further research because of the need to optimize clinical outcome in these patients and to better define the role of hematoma evacuation in the care of these patients. |
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| Standard of Care | 50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care (e.g. no surgical intervention). These patients will be matched to the surgical patients based on age, gender, and location of hemorrhage. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NICO BrainPathâ„¢ System | Device | Patients who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for participation in the trial by their treating physician. Once blood pressure has been stabilized and the best medical treatment has been determined, the patient will need to undergo a standard of care, repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPathâ„¢ system. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the NICO BrainPathâ„¢ hematoma evacuation system | The primary objective of this study is to determine the effectiveness of the NICO BrainPathâ„¢ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve <15 ml residual hematoma volume immediately after the surgery. | immediately after the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of mortality and complication rate. | Additionally, the study aims to compare the mortality and complication rate of patients who undergo minimally invasive, navigation guided endoport based evacuation of intracerebral hematoma with NICO BrainPathâ„¢ System as compared to non-operative, supportive standard of care until six months post-operative. | 6 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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Male and females between the ages of 18-80 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Haran Ramachandran, MD | Lahey Clinic | Principal Investigator |
| Zoher Ghogawala, MD | Lahey Clinic | Study Chair |
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