Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation... | NCT01827046

ID	Type	Description	Link
U01NS080824	U.S. NIH Grant/Contract		View source
ICH02	Other Identifier	Other

Status Module

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH
Genentech, Inc.	INDUSTRY
Emissary International LLC	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MIS plus rt-PA management	Experimental	Subjects randomized to the Minimally Invasive Surgery (MIS) plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.	Drug: rt-PA
Medical management	No Intervention	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rt-PA	Drug	Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted)	Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 365 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). Ictus refers to symptom onset. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death.	Day 365

Secondary Outcomes

Measure	Description	Time Frame
Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 365 Days Post Ictus (Adjusted)	Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 365 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3.

Other Outcomes

Measure	Description	Time Frame
Mortality and Safety Events: First-week (Operative) Mortality	Mortality and Safety events: By group comparison of mortality within the first 7 days post randomization.	Day 7
Mortality and Safety Events: All Cause Mortality

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (computerized tomography (CT), computerized tomography angiography (CTA), etc.), with a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6.
Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth < 5 mL as measured by ABC/2 method).
Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).
Ability to randomize between 12 and 72 hours after dCT.
Systolic Blood Pressure (SBP) < 180 mmHg sustained for six hours recorded closest to the time of randomization.
Historical Rankin score of 0 or 1.
Age ≥ 18 and older.

Exclusion Criteria:

Infratentorial hemorrhage.
Intraventricular hemorrhage (IVH) requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. External ventricular drain (EVD) to treat intracranial pressure (ICP) is allowed.
Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.
Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1 year) hemorrhage diagnosed with radiographic imaging.
Patients with unstable mass or evolving intracranial compartment syndrome.
Platelet count < 100,000; international normalized ratio (INR) > 1.4.
Any irreversible coagulopathy or known clotting disorder.
Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but not limited to NovoSeven, Fresh Frozen Plasma (FFP), and/or vitamin K).
Subjects requiring long-term anti-coagulation are excluded. Reversal of anti-coagulation is permitted for medically stable patients who can realistically tolerate the short term risk of reversal. Patient must not require Coumadin (anticoagulation) during the first 30 days, and normalized coagulation parameters must be demonstrated, monitored closely and maintained during the period of brain instrumentation.
Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention.
Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
Allergy/sensitivity to rt-PA.
Prior enrollment in the study.
Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible.
Not expected to survive to the day 365 visit due to co-morbidities and/or are do not resuscitate (DNR)/ do not intubate (DNI) status prior to randomization.
Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
Patients with a mechanical heart valve. Presence of bio-prosthetic valve(s) is permitted.
Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis.
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rt-PA removal of the ICH.
Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Name	Affiliation	Role
Daniel F. Hanley, MD	Johns Hopkins University	Study Chair
Mario Zuccarello, MD	University of Cincinnati	Principal Investigator
Issam Awad, MD	University of Chicago	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Banner Good Samaritan Hospital

PubMed Identifier	Type	Citation	Retractions
42326800	Derived	Murray ON, Jenkins DA, Walborn N, Patel HC, Harston G, Cootes T, Klijn CJ, Ziai W, Hanley DF, Hammerbeck U, Parry-Jones AR. Corticospinal tract risk modifies motor recovery after minimally invasive surgery for intracerebral hemorrhage: a secondary analysis of MISTIE-III. medRxiv [Preprint]. 2026 Jun 11:2026.06.10.26354920. doi: 10.64898/2026.06.10.26354920.
40250866	Derived	Cooper DC, Abramson E, Ziai WC, Flaherty ML, Shah VA, Avadhani R, Ostapkovich N, Carhuapoma L, Awad I, Zuccarello M, Hanley D, Sansing LH. Intracerebral haemorrhage laterality and associations with mood and pain: a MISTIE III substudy. Stroke Vasc Neurol. 2025 Dec 23;10(6):734-742. doi: 10.1136/svn-2024-003755.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MIS Plus Rt-PA Management	Subjects randomized to the Minimally Invasive Surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jul 25, 2018	Aug 19, 2019

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG00062(52 to 70) BG00162(53 to 71) BG00262(52 to 71)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00091 BG001103 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00034 BG00134 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Australia

Title	Measurements
	BG0002 BG0012 BG002

Tobacco use

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00050 BG00139 BG002

Cocaine use

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00011 BG0019 BG002

On anticoagulants

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00024 BG00110 BG002

Hormone replacement therapy

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0001 BG0013 BG002

Hyperlipidaemia medication compliant

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00096 BG00193 BG002

Antiplatelet therapy

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00067 BG00177 BG002

Diabetes

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00072 BG00167 BG002

Hypertension

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000241 BG001240 BG002

Other cardiovascular disease

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00038 BG00134 BG002

GCS score at randomization

Glasgow Coma Scale (GCS) scores range from 15 (fully conscious) to 3 (Deep coma)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
3-8	BG00064 BG00163 BG002

NIHSS score at randomization

NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The maximum possible score is 42, with the minimum score being a 0. Stroke severity is scored in the following way:0=No stroke symptoms,1-4=Minor stroke, 5-15=Moderate stroke,16-20=Moderate to severe stroke, 21-42=Severe stroke

Median

Inter-Quartile Range

Units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00019(15 to 23) BG001

Diagnostic CT at presentation - IntraCerebral Hemorrhage (ICH) volume (mL)

Median

Inter-Quartile Range

Title

Denominators

Categories

Title	Measurements
	BG00042.7(30.4 to 54.5) BG00141.5(30.9 to 55.3) BG002

Diagnostic CT at presentation - IntraVentricular Hemorrhage (IVH) volume (mL)

Median

Inter-Quartile Range

Title

Denominators

Categories

Title	Measurements
	BG0000(0 to 1.7) BG0010(0 to 1.9) BG002

Stability CT(last CT before randomization) IntraCerebral Hemorrhage (ICH) volume (mL)

Median

Inter-Quartile Range

Title

Denominators

Categories

Title	Measurements
	BG00045.8(35.4 to 59.6) BG00145.3(35.4 to 57.2) BG002

Stability CT(last CT before randomization) IntraVentricular Hemorrhage (IVH) volume (mL)

Median

Inter-Quartile Range

Title

Denominators

Categories

Title	Measurements
	BG0000.3(0 to 3.1) BG0010.4(0 to 3.2) BG002

Ventilated at randomization

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000107 BG001102 BG002

Blood pressure at presentation

Median

Inter-Quartile Range

mm Hg

Title

Denominators

Categories

Systolic BP (mm Hg)

Title	Measurements
	BG000177(155 to 208) BG001176(158 to 200) BG002

Blood pressure at randomization

Median

Inter-Quartile Range

mm Hg

Title

Denominators

Categories

Systolic BP (mm Hg)

Title	Measurements
	BG000138(130 to 148) BG001138(131 to 148) BG002

Time from stroke to diagnostic CT (h)

Median

Inter-Quartile Range

Hours

Title

Denominators

Categories

Title	Measurements
	BG0002.2(1.1 to 6.0) BG0011.9(1.2 to 4.8) BG002

Time from stroke to stability CT (h)

Median

Inter-Quartile Range

Hours

Title

Denominators

Categories

Title	Measurements
	BG00036.4(23.4 to 52.6) BG00136.3(23.6 to 48.6) BG002

Clot location

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Deep	BG000163 BG001144 BG002

mRS score before stroke

Score 0 = No symptoms. Score 1 = Having symptoms but no significant disability, and is able to carry out all usual activities.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0	BG000230 BG001233

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted)

Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 365 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). Ictus refers to symptom onset.

The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death.

Includes participants with mRS scores available at day 365. Number and proportions reported refer to number of participants and proportions with Modified Rankin Score 0-3

Posted

Count of Participants

Participants

Day 365

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants	OG000249 OG001240

Title

Denominators

Categories

mRS 0-3

Title	Measurements
	OG000110 OG001100

mRS 4-6

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.73		Risk Difference (RD)	2			2-Sided	95	-6.8	10.7					Superiority
OG000 OG001	Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location	Multivariate logit model

Secondary

Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 365 Days Post Ictus (Adjusted)

Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 365 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3.

Those with non-missing mRS scores at 365 days post ictus

Posted

Count of Participants

Participants

Day 365

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management

Secondary

All Cause Mortality Longitudinally From Ictus to 365 Days (Adjusted)

By group comparison of mortality from ictus to 365 days adjusted for baseline severity.

Posted

Count of Participants

Participants

Day 365

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants	OG000

Secondary

Clot Removal (Amount of Residual Blood)

Relationship between clot removal as an Area Under the Curve (AUC) clot-assessment that estimates the time-averaged clot volume from ictus to end of treatment (EOT i.e. 24 hours after last dose) as AUC clot exposure and functional outcome (proportion 0-3 Modified Rankin Scale (mRS)).

Includes patients who survived through the dosing period

Posted

Mean

Standard Deviation

10mL x days

24 hours after last dose

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts

Secondary

Patient Disposition: Home Days Over 365 Days Time From Ictus.

By group comparison of cumulative days at home during the 365 days post ictus.

Includes only patients with cumulative home days at any time during the 365 days of follow-up.

Posted

Median

Inter-Quartile Range

Days

During 365 days of follow-up

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants

Secondary

Patient Disposition: Patient Location at 365 Days Post Ictus (i.e., Good vs. Bad Location) (Adjusted)

Patient disposition: By group comparison of residential location at day 365 post ictus adjusted for baseline severity.

Good locations refers to home and rehabilitation; and bad locations refers to acute care, long-term care and death.

Posted

Count of Participants

Participants

Day 365

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants

Secondary

Dichotomized, Adjudicated, Cross-sectional Modified Rankin Scale (mRS) Score 0-3 vs. 4-6 180 Days Post Ictus (Adjusted)

Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 180 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

Includes patients who were not lost to followup at day 180

Posted

Count of Participants

Participants

Day 180

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management

Secondary

Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 180 Days Post Ictus (Adjusted)

Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 180 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

Patients were included if they were not lost to followup at day 180

Posted

Count of Participants

Participants

Day 180

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management

Secondary

Type and Intensity of ICU Management: ICU Days

By group comparison of cumulative number of days in the Intensive Care Unit (ICU) in a hospital

Includes patients with cumulative ICU days during the 365 days of follow-up

Posted

Median

Inter-Quartile Range

Days

Up to 365 days

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants

Secondary

Type and Intensity of ICU Management: Hospital Days

By group comparison of total number of days in the hospital

Posted

Median

Inter-Quartile Range

Days

Up to 365 days

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants	OG000

Secondary

EQ-VAS

By group comparison of EQ-VAS at day 365 post ictus. The EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where subjects draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).

Includes patients who survived or were not lost to followup through 365 days

Posted

Median

Inter-Quartile Range

score on a scale

Day 365

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts

Secondary

EuroQol 5 Dimensional Scale (EQ-5D)

By group comparison of EQ-5D at day 365 post ictus. The EuroQol 5 Dimensional Scale (Eq-5D) is a self-reported measure of health status. It is arranged to assess domains related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each domain, codes were 1=no problems, 2=some problems, 3=extreme problems, and 9=unknown. Having a problem in at least 1 domain was coded as 1 (originally represented by 2 or 3) and no problems as 0 (originally represented by 1) .

Patients were included if they survived or were not lost to followup through 365 days

Posted

Count of Participants

Participants

Day 365

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Other Pre-specified

Mortality and Safety Events: First-week (Operative) Mortality

Mortality and Safety events: By group comparison of mortality within the first 7 days post randomization.

Posted

Count of Participants

Participants

Day 7

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants	OG000

Other Pre-specified

Mortality and Safety Events: All Cause Mortality

By group comparison of mortality from all causes within the first 30 days post randomization.

Posted

Count of Participants

Participants

Day 30

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants	OG000

Other Pre-specified

Mortality and Safety Events: Adjudicated Symptomatic Brain Bleeding Within 72 Hours After Last Dose

By group comparison of the percentage of subjects experiencing one or more adjudicated symptomatic brain bleeding events within the first 30 days post randomization.

Posted

Count of Participants

Participants

72 hours after last dose

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants

Other Pre-specified

Mortality and Safety Events: Adjudicated Bacterial Brain Infection

By group comparison of the percentage of subjects experiencing one or more adjudicated brain bacterial infection events within the first 30 days post randomization.

Posted

Count of Participants

Participants

Day 30

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants

Other Pre-specified

Mortality and Safety Events: Total Serious Adverse Events (SAE) at 30 Days

By group comparison of the total number of adjudicated serious adverse events that occurred within the first 30 days post randomization.

Posted

Number

Number of events

Day 30

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants	OG000

Other Pre-specified

Mortality and Safety Events: Summary of AE and SAE by MedDRA Code and Grouped by Organ System Within the First 30 Days Post Ictus

By group comparison of the total number of adjudicated adverse events (AE) and serious adverse events (SAE) across all coded organ systems that occurred within the first 30 days post ictus.

Posted

Number

Number of events

Day 30

ID	Title	Description
OG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
OG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.	48	250	75	250	205	250
EG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.	62	249	84	249	169	249

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac disorders	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events3 affected250 at risk EG0012 events1 affected249 at risk
Gastrointestinal disorders	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events3 affected250 at risk EG0016 events4 affected249 at risk
General disorders and administration site conditions	General disorders	MedDRA	Systematic Assessment	EG00013 events13 affected250 at risk EG00127 events26 affected249 at risk
Non-neurological infections	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events2 affected250 at risk EG0018 events4 affected249 at risk
Injury, Poisoning and procedural complications	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected250 at risk EG0010 events0 affected249 at risk
Metabolism and nutrition disorders	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected250 at risk EG0010 events0 affected249 at risk
Neoplasms(Benign, malignant or unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected250 at risk EG0010 events0 affected249 at risk
Nervous system disorders	Nervous system disorders	MedDRA	Systematic Assessment	EG00041 events17 affected250 at risk EG00162 events33 affected249 at risk
Psychiatric disorders	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected250 at risk EG0012 events1 affected249 at risk
Renal and urinary disorders	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected250 at risk EG0014 events1 affected249 at risk
Respiratory, thoracic and mediastinal disirders	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00040 events26 affected250 at risk EG00125 events14 affected249 at risk
Vascular disorders	Vascular disorders	MedDRA	Systematic Assessment	EG00011 events6 affected250 at risk EG0010 events0 affected249 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood and lymphatic system disorders	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 events2 affected250 at risk EG0010 events0 affected249 at risk
Cardiac disorders	Cardiac disorders	MedDRA	Systematic Assessment	EG00015 events3 affected250 at risk EG00111 events5 affected249 at risk
Gastrointestinal disorders	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 events5 affected250 at risk EG00117 events7 affected249 at risk
General disorders and administration site conditions	General disorders	MedDRA	Systematic Assessment	EG00053 events17 affected250 at risk EG00142 events12 affected249 at risk
Hepatobiliary disorders	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected250 at risk EG0012 events2 affected249 at risk
Immune system disorders	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected250 at risk EG0011 events1 affected249 at risk
Infections, non-neurologic	Infections and infestations	MedDRA	Systematic Assessment	EG00016 events9 affected250 at risk EG00141 events25 affected249 at risk
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 events1 affected250 at risk EG0013 events2 affected249 at risk
Investigations	Investigations	MedDRA	Systematic Assessment	EG00012 events1 affected250 at risk EG00120 events7 affected249 at risk
Metabolism and nutrition disorders	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00017 events3 affected250 at risk EG00120 events6 affected249 at risk
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events2 affected250 at risk EG0010 events0 affected249 at risk
Neoplasms: benign, malignant, Unspecified (incl cysts and polyps)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected250 at risk EG0012 events1 affected249 at risk
Nervous system disorders	Nervous system disorders	MedDRA	Systematic Assessment	EG000216 events108 affected250 at risk EG001107 events47 affected249 at risk
Psychiatric disorders	Psychiatric disorders	MedDRA	Systematic Assessment	EG00014 events6 affected250 at risk EG00113 events5 affected249 at risk
Renal and urinary disorders	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 events3 affected250 at risk EG0015 events2 affected249 at risk
Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00067 events30 affected250 at risk EG00162 events33 affected249 at risk
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected250 at risk EG0013 events1 affected249 at risk
Vascular disorders	Vascular disorders	MedDRA	Systematic Assessment	EG00039 events14 affected250 at risk EG00129 events13 affected249 at risk

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D057057	Serine Proteases
D010960	Plasminogen Activators
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001685	Biological Factors

ID	Title	Description
BG000	MIS Plus Rt-PA Management	Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution. rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
BG001	Medical Management	Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
BG002	Total	Total of all reporting groups