Trial Outcomes & Findings for Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation (NCT NCT00224770)
NCT ID: NCT00224770
Last Updated: 2015-06-18
Results Overview
Percentage of participants who died during the first 30 days after randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
30 days from randomization
Results posted on
2015-06-18
Participant Flow
110 patients were randomized to the trial, and 31 were recruited as pilot patients.
Each study center was required to demonstrate proficiency in the technical aspects of enrollment, stabilization, surgery, and drug administration. This proficiency was demonstrated on at least one pilot patient prior to randomization of the first patient in the investigational cohort of 110 randomized patients.
Participant milestones
| Measure |
Medical Management
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
54
|
14
|
|
Overall Study
COMPLETED
|
38
|
52
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
0
|
Reasons for withdrawal
| Measure |
Medical Management
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
0
|
Baseline Characteristics
Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
Baseline characteristics by cohort
| Measure |
Medical Management
n=42 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
60 years
n=7 Participants
|
59 years
n=5 Participants
|
61 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
53 participants
n=7 Participants
|
14 participants
n=5 Participants
|
108 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days from randomizationPercentage of participants who died during the first 30 days after randomization.
Outcome measures
| Measure |
Medical Management
n=42 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Safety Outcome Number 1: Rate of Mortality
|
9.5 percentage of participants
Interval 3.3 to 20.5
|
14.8 percentage of participants
Interval 7.6 to 25.1
|
7.1 percentage of participants
Interval 0.4 to 29.7
|
PRIMARY outcome
Timeframe: 7 days from randomizationPercentage of participants who died during the first 7 days after randomization.
Outcome measures
| Measure |
Medical Management
n=42 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Safety Outcome Number 2: Rate of Procedure-related Mortality
|
0 percentage of participants
Interval 0.0 to 6.9
|
5.6 percentage of participants
Interval 1.5 to 13.7
|
0 percentage of participants
Interval 0.0 to 19.3
|
PRIMARY outcome
Timeframe: 30 days from randomizationPercentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.
Outcome measures
| Measure |
Medical Management
n=42 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
|
2.4 percentage of participants
Interval 0.1 to 10.8
|
0 percentage of participants
Interval 0.0 to 5.4
|
0 percentage of participants
Interval 0.0 to 19.3
|
PRIMARY outcome
Timeframe: 72 hours post last doseThe difference in the rate of symptomatic rebleeding 72 hours post last dose.
Outcome measures
| Measure |
Medical Management
n=42 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Safety Outcome Number 4: Rate of Symptomatic Rebleeding
|
2.4 percentage of participants
Interval 0.1 to 10.8
|
5.6 percentage of participants
Interval 1.5 to 13.7
|
0 percentage of participants
Interval 0.0 to 19.3
|
PRIMARY outcome
Timeframe: 180 days from randomizationPercentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead
Outcome measures
| Measure |
Medical Management
n=38 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=52 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180
|
23.7 percentage of participants
Interval 12.9 to 37.7
|
34.6 percentage of participants
Interval 23.7 to 46.9
|
42.9 percentage of participants
Interval 20.6 to 67.5
|
SECONDARY outcome
Timeframe: 180 days from randomizationOrdinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.
Outcome measures
| Measure |
Medical Management
n=38 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=52 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Ordinal Modified Rankin Scale (mRS) at Day 180
|
4 units on a scale
Interval 4.0 to 6.0
|
4 units on a scale
Interval 3.0 to 6.0
|
4 units on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 365 days from randomizationOrdinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.
Outcome measures
| Measure |
Medical Management
n=24 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=20 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=12 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Ordinal Modified Rankin Scale (mRS) at Day 365
|
4.5 units on a scale
Interval 3.5 to 6.0
|
4 units on a scale
Interval 2.0 to 6.0
|
3.5 units on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Time from randomization until end of treatment, up to 10 daysThe percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan.
Outcome measures
| Measure |
Medical Management
n=42 Participants
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Clot Size Reduction by End of Treatment
|
3.9 percentage of blood clot resolved
Interval -0.06 to 10.2
|
64.3 percentage of blood clot resolved
Interval 43.3 to 74.1
|
69.5 percentage of blood clot resolved
Interval 59.0 to 86.0
|
SECONDARY outcome
Timeframe: Time from post-operation until end of treatment, up to 10 daysPopulation: Analysis population only includes surgical patients.
The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients.
Outcome measures
| Measure |
Medical Management
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 Participants
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 Participants
Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Post-operative Clot Size Reduction
|
—
|
56.7 percentage of blood clot resolved
Interval 23.6 to 68.4
|
-6.4 percentage of blood clot resolved
Interval -21.3 to 4.0
|
Adverse Events
Medical Management
Serious events: 23 serious events
Other events: 24 other events
Deaths: 0 deaths
MISTIE Surgical Management
Serious events: 28 serious events
Other events: 41 other events
Deaths: 0 deaths
ICES Surgical Management
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medical Management
n=42 participants at risk
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 participants at risk
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 participants at risk
Intraoperative stereotactic CT-Guided Endoscopic Surgery
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
4.8%
2/42 • Number of events 2
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Infections and infestations
Bacteremia
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Cardiac disorders
Cardiac arrest
|
7.1%
3/42 • Number of events 3
|
1.9%
1/54 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
General disorders
Death NOS
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/42
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Edema cerebral
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
Epistaxis
|
0.00%
0/42
|
1.9%
1/54 • Number of events 2
|
0.00%
0/14
|
|
Vascular disorders
Hypertension
|
0.00%
0/42
|
3.7%
2/54 • Number of events 3
|
0.00%
0/14
|
|
Vascular disorders
Hypotension
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hemorrhage: Tissue, Enlargement
|
2.4%
1/42 • Number of events 1
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hemorrhage: Tissue, New
|
0.00%
0/42
|
3.7%
2/54 • Number of events 2
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hemorrhage: Ventricular system, New
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hypertension
|
9.5%
4/42 • Number of events 4
|
3.7%
2/54 • Number of events 3
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Ischemia cerebrovascular
|
9.5%
4/42 • Number of events 4
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Infections and infestations
Lung infection
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Infections and infestations
Endocarditis
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left renal mass
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Cardiac disorders
PVC's, bigemeny
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 2
|
0.00%
0/54
|
0.00%
0/14
|
|
Nervous system disorders
Anoxic brain injury
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitits
|
2.4%
1/42 • Number of events 1
|
9.3%
5/54 • Number of events 5
|
7.1%
1/14 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pulmonary embolism
|
2.4%
1/42 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.9%
5/42 • Number of events 5
|
11.1%
6/54 • Number of events 6
|
0.00%
0/14
|
|
Nervous system disorders
Seizure
|
4.8%
2/42 • Number of events 3
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • Number of events 1
|
5.6%
3/54 • Number of events 5
|
0.00%
0/14
|
|
Nervous system disorders
Stroke
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Ventilatory failure
|
0.00%
0/42
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage: Catheter Tract, New
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage: Catheter Tract, Enlargement
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage: Ventricular system, Enlargement
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
7.1%
1/14 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Infections and infestations
Enterocolitis infectious
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Nervous system disorders
Herniation
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Nervous system disorders
Hydrocephalus
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Cardiac disorders
Myocardial infarction
|
4.8%
2/42 • Number of events 2
|
0.00%
0/54
|
0.00%
0/14
|
|
Cardiac disorders
Sinus bradycardia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
General disorders
Sudden death NOS
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
|
Vascular disorders
Thromboembolic event
|
7.1%
3/42 • Number of events 3
|
0.00%
0/54
|
0.00%
0/14
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/54
|
0.00%
0/14
|
Other adverse events
| Measure |
Medical Management
n=42 participants at risk
Standard of care medical management as per American Heart Association (AHA) guidelines.
|
MISTIE Surgical Management
n=54 participants at risk
Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).
MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
This includes 54 intent-to-treat patients, and excludes 27 pilots.
|
ICES Surgical Management
n=14 participants at risk
Intraoperative stereotactic CT-Guided Endoscopic Surgery
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.
This includes 14 intent-to-treat patients, and excludes 4 pilots.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute renal failure
|
2.4%
1/42 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
11.9%
5/42 • Number of events 5
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.4%
1/42 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
General disorders
Fever
|
14.3%
6/42 • Number of events 6
|
24.1%
13/54 • Number of events 14
|
21.4%
3/14 • Number of events 3
|
|
Renal and urinary disorders
Hematuria
|
4.8%
2/42 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/42 • Number of events 1
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Vascular disorders
Hypertension
|
9.5%
4/42 • Number of events 4
|
11.1%
6/54 • Number of events 6
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
2/42 • Number of events 2
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
2/42 • Number of events 3
|
1.9%
1/54 • Number of events 1
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
1/42 • Number of events 1
|
11.1%
6/54 • Number of events 6
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/42 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/42 • Number of events 1
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.4%
1/42 • Number of events 1
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Infections and infestations
Lung infection
|
4.8%
2/42 • Number of events 3
|
1.9%
1/54 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain
|
4.8%
2/42 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
7/42 • Number of events 7
|
11.1%
6/54 • Number of events 6
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
Seizure
|
7.1%
3/42 • Number of events 5
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Cardiac disorders
Sinus bradycardia
|
4.8%
2/42 • Number of events 2
|
0.00%
0/54
|
0.00%
0/14
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • Number of events 1
|
9.3%
5/54 • Number of events 5
|
0.00%
0/14
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Infections and infestations
Urinary tract infection
|
11.9%
5/42 • Number of events 6
|
16.7%
9/54 • Number of events 9
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Ventilatory failure
|
2.4%
1/42 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/42
|
14.8%
8/54 • Number of events 11
|
0.00%
0/14
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/42
|
9.3%
5/54 • Number of events 6
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/42
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/42
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/42
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/42
|
7.4%
4/54 • Number of events 4
|
0.00%
0/14
|
|
Vascular disorders
Hypotension
|
0.00%
0/42
|
5.6%
3/54 • Number of events 5
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hemorrhage: Catheter Tract, Enlargement
|
0.00%
0/42
|
5.6%
3/54 • Number of events 4
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hemorrhage: Catheter Tract, New
|
0.00%
0/42
|
11.1%
6/54 • Number of events 6
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hemorrhage: Tissue, Enlargement
|
0.00%
0/42
|
5.6%
3/54 • Number of events 4
|
0.00%
0/14
|
|
Nervous system disorders
Intracranial hemorrhage: Ventricular system, Enlargement
|
0.00%
0/42
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
General disorders
Localized edema
|
0.00%
0/42
|
5.6%
3/54 • Number of events 3
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42
|
9.3%
5/54 • Number of events 5
|
0.00%
0/14
|
|
General disorders
HCAP
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Wound reclosure after serious fluid leak
|
0.00%
0/42
|
0.00%
0/54
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the funding agency (NIH/NINDS) can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the funding agency for review. The funding agency cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER