Intracranial HematomaNCT04466553
MIS Hematoma Evacuation
An observational study of Intracranial Hematoma, run by Lahey Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Hematoma
- What is being tested?
- NICO BrainPath™ System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Aug 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Male and females between the ages of 18-80 years old.
Who may be able to join
- 18 and 80 years of age, inclusive
- Spontaneous supratentorial, intracerebral hematoma ICH >30 ml measured by the ABC/2 method.
- Location of Hemorrhage: Lobar, Putaminal and/or Caudate
- A Glasgow Coma Scale (GCS) of 4 or greater
- 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).
Who cannot join
- Pupils dilated and fixed
- Rapidly deteriorating patient (at the discretion of the surgeon)
- Primary Thalamic Bleed
- Intraventricular Blood (more than 50 % of either ventricle, visual estimate)
- ICH secondary to aneurysm
- Arteriovenous malformation (AVM)
Show all 11Show fewer
- Tumor
- Moya-Moya
- Sinus thrombosis
- Platelet count <100,000, INR >1.4
- Known coagulopathy, on anticoagulants that cannot be reversed
About this study
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.
Read the detailed 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.
- Conditions
- Intracranial Hematoma
- Being tested
- NICO BrainPath™ System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICO BrainPath™ SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NICO BrainPath™ Patients | 50 patients will be enrolled in Group A NICO BrainPath™ system.
The NICO BrainPath™ 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 BrainPath™ system as being safe and effective. Additionally, previous studies concluded that lesser ICH removal was correlated with mortality benefit and that the NICO BrainPath™ 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. Receives: Device: NICO BrainPath™ System | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the surgery.
Secondary outcomes (1)
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.
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study startOct 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: The study did not begin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haran Ramachandran, MD, Principal investigator, Lahey ClinicZoher Ghogawala, MD, Study chair, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466553
- Sponsor's protocol ID
- 20203097
- Status last verified
- Dec 2021
- First submitted
- 1 Jul 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIS Hematoma Evacuation
- ClinicalTrials.gov ID
- NCT04466553
- Acronym / sponsor ID
- 20203097
- Conditions
- Intracranial Hematoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study did not begin.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NICO BrainPath™ Patients | – | Device: NICO BrainPath™ System50 patients will be enrolled in Group A NICO BrainPath™ system. The NICO BrainPath™ 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 BrainPath™ system as being safe and effective. Additionally, previous studies concluded that lesser ICH removal was correlated with mortality benefit and that the NICO BrainPath™ 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and females between the ages of 18-80 years old.
Key inclusion criteria (5 listed)
- 18 and 80 years of age, inclusive
- Spontaneous supratentorial, intracerebral hematoma ICH >30 ml measured by the ABC/2 method.
- Location of Hemorrhage: Lobar, Putaminal and/or Caudate
- A Glasgow Coma Scale (GCS) of 4 or greater
- 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).
Key exclusion criteria (11 listed)
- Pupils dilated and fixed
- Rapidly deteriorating patient (at the discretion of the surgeon)
- Primary Thalamic Bleed
- Intraventricular Blood (more than 50 % of either ventricle, visual estimate)
- ICH secondary to aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NICO BrainPath™ SystemPatients 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. | Device | NICO BrainPath™ Patients |
Primary outcome
Effectiveness of the NICO BrainPath™ hematoma evacuation system
Time frame: immediately after the surgery.
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.
1 secondary outcome
Comparison of mortality and complication rate.
Time frame: 6 months post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haran Ramachandran, MD principal investigator
Lahey Clinic
Zoher Ghogawala, MD study chair
Lahey Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hematoma, run by Lahey Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the NICO BrainPath™ hematoma evacuation system (time frame: immediately after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.