MIS Hematoma Evacuation

Intracranial Hematoma Clinical Trial

Official title:

MIS Hematoma Evacuation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04466553
• Other study ID #: 20203097
• Status: Withdrawn
• Start date: October 2021
• Est. completion date: August 2022

Study information

• Verified date: December 2021
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ 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 BrainPath™ 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 BrainPath™ 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 BrainPath™ System. The patient population receiving non-operative supportive care will be matched to the surgical patients based on age, gender, and location of hemorrhage.

Description:

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 BrainPath™ 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18 and 80 years of age, inclusive

2. Spontaneous supratentorial, intracerebral hematoma ICH >30 ml measured by the ABC/2 method.

3. Location of Hemorrhage: Lobar, Putaminal and/or Caudate

4. A Glasgow Coma Scale (GCS) of 4 or greater

5. Historical Modified Rankin Score (mRS) of 0 (no symptoms of neurological disability) or 1 (no significant disability despite symptoms, able to carry out usual duties and activities).

Exclusion Criteria:

1. Pupils dilated and fixed

2. Rapidly deteriorating patient (at the discretion of the surgeon)

3. Primary Thalamic Bleed

4. Intraventricular Blood (more than 50 % of either ventricle, visual estimate)

5. ICH secondary to aneurysm

6. Arteriovenous malformation (AVM)

7. Tumor

8. Moya-Moya

9. Sinus thrombosis

10. Platelet count <100,000, INR >1.4

11. Known coagulopathy, on anticoagulants that cannot be reversed

Related Conditions & MeSH terms

• Hematoma
• Intracranial Hematoma

Intervention

Device:
• NICO BrainPath™ System
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 BrainPath™ system.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the NICO BrainPath™ hematoma evacuation system	The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ 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.
Secondary	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 BrainPath™ System as compared to non-operative, supportive standard of care until six months post-operative.	6 months post-op