Intraventricular Hemorrhage
Conditions
Keywords
intraventricular hemorrhage thrombolysis
Brief summary
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH \< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Interventions
DRUGAlteplase
1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses
OTHERNormal saline
1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Emissary International LLC
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 * Symptom onset less than 24 hrs prior to diagnostic CT scan * Spontaneous ICH less than or equal to 30 cc or primary IVH * IVH obstructing 3rd and/or 4th ventricles * ICH clot stability at 6 hours or more post IVC placement * IVH clot stability at 6 hours or more post IVC placement * Catheter tract bleeding stability 6 hours or more post IVC placement * EVD placed per standard medical care * SBP less than 200 mmHg sustained for 6 hours prior to drug administration * Able to randomize within 72 hours of diagnostic CT scan * Historical Rankin of 0 or 1
Exclusion criteria
* Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor * Presence of a choroid plexus vascular malformation or Moyamoya * Clotting disorders * Platelet count less than 100,000, INR greater than 1.4 * Pregnancy * Infratentorial hemorrhage * SAH at clinical presentation * ICH/IVH enlargement that cannot be stabilized in the treatment time window * Ongoing internal bleeding * Superficial or surface bleeding * Prior enrollment in the study * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial. * No subject or legal representative to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis | 180 days | Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death). |
| Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis | 180 days | The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death). |
| Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis | 180 days | The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death). |
| Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 | 180 days | The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death). |
| Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 | 30 days and 180 days | Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. 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 (perfect health without symptoms) to 6 (death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Critical Care Management - Mechanical Ventilation | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Intensity of Critical Care Management - Pressors | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Intensity of Critical Care Management - Shunts | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Intensity of Critical Care Management - All Infections | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Intensity of Critical Care Management - Pneumonia | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Safety/Mortality - Mortality Within 30 Days | 30 days | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Safety/Mortality - Bacterial Brain Infections Within 30 Days | 30 days | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Safety/Mortality - Systematic Bleeds Within 72 Hours | 72 hours | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Safety/Mortality - Systematic Bleeds Within 30 Days | 30 days | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Adverse and Serious Adverse Events | 180 days | Assessment of number of adverse and serious adverse events by treatment group. |
| Predicting Hazards of Death by Treatment Group | 180 days | Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group. |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) | 180 days | Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) | 180 days | Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) | 180 days | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death). |
| Functional Status - Barthel Index | 180 days | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence. |
| Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability | 180 days | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 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. |
| Functional Status - National Institutes of Health Stroke Scale (NIHSS) | 180 days | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke). |
| Quality of Life - Stroke Impact Scale (SIS) - Strength | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Mobility | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Hand Function | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Communication | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Thinking | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Emotion | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Participation | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Quality of Life - Stroke Impact Scale (SIS) - Recovery | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Intensity of Critical Care Management - Hospital Days | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) | 180 days | Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals 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). |
| All Cause Mortality | 180 days | — |
| Clot Removal (Amount of Residual Blood) | 72 hours | Change in blood volume measured between stability scan and end of treatment scan |
| Intensity of Critical Care Management - ICU Days | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Intensity of Critical Care Management - ICP Management | 30 days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
Countries
Brazil, Canada, Germany, Hungary, Israel, Spain, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alteplase Administration of alteplase via the intraventricular catheter
Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 249 |
| Saline Placebo 1 ml of normal saline administered via the intraventricular catheter
Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 251 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 6 |
Baseline characteristics
| Characteristic | Alteplase | Saline Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 67 Participants | 79 Participants | 146 Participants |
| Age, Categorical Between 18 and 65 years | 182 Participants | 172 Participants | 354 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 92 Participants | 78 Participants | 170 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 144 Participants | 161 Participants | 305 Participants |
| Region of Enrollment Brazil | 1 participants | 3 participants | 4 participants |
| Region of Enrollment Canada | 3 participants | 6 participants | 9 participants |
| Region of Enrollment Germany | 21 participants | 18 participants | 39 participants |
| Region of Enrollment Hungary | 7 participants | 6 participants | 13 participants |
| Region of Enrollment Israel | 13 participants | 24 participants | 37 participants |
| Region of Enrollment Spain | 9 participants | 7 participants | 16 participants |
| Region of Enrollment Switzerland | 1 participants | 3 participants | 4 participants |
| Region of Enrollment United Kingdom | 4 participants | 4 participants | 8 participants |
| Region of Enrollment United States | 190 participants | 180 participants | 370 participants |
| Sex: Female, Male Female | 105 Participants | 117 Participants | 222 Participants |
| Sex: Female, Male Male | 144 Participants | 134 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 165 / 249 | 178 / 251 |
| serious Total, serious adverse events | 114 / 249 | 151 / 251 |
Outcome results
Primary
Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3
Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. 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 (perfect health without symptoms) to 6 (death).
Time frame: 30 days and 180 days
Population: All the non-missing mRS scores at 30 days and 180 days were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alteplase | Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 | Day 30 | 20.4 Percentage of participants |
| Alteplase | Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 | Day 180 | 48.0 Percentage of participants |
| Saline Placebo | Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 | Day 30 | 16.5 Percentage of participants |
| Saline Placebo | Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 | Day 180 | 45.7 Percentage of participants |
Comparison: Logit mRS scores 0-3 at 30 daysp-value: 0.38495% CI: [0.75, 2.1]Generalized Estimating Equation Model
Comparison: Logit mRS scores 0-3 at 180 daysp-value: 0.96495% CI: [0.62, 1.64]Generalized Estimating Equation Model
Primary
Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis
The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All the non-missing mRS scores at 180 days were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alteplase | Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis | 4 mRS score |
| Saline Placebo | Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis | 4 mRS score |
p-value: 0.48495% CI: [0.63, 1.25]Generalized ordered Logit Model
p-value: <0.00195% CI: [0.28, 0.71]Generalized ordered Logit Model
Primary
Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis
Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All the non-missing mRS scores at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis | 47.6 percentage of participants |
| Saline Placebo | Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis | 44.9 percentage of participants |
p-value: 0.55495% CI: [-0.062, 0.115]Chi-squared
p-value: 0.46595% CI: [0.75, 1.87]Multivariable Logit Model
Primary
Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis
The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All the non-missing mRS scores at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis | 64.2 percentage of participants |
| Saline Placebo | Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis | 61.6 percentage of participants |
p-value: 0.55295% CI: [-0.059, 0.111]Chi-squared
p-value: 0.3595% CI: [0.8, 1.9]Multivariable Logit Model
Primary
Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3
The modified Rankin Scale (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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All the non-missing mRS scores at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 | 47.6 percentage of participants |
| Saline Placebo | Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 | 44.9 percentage of participants |
p-value: 0.42895% CI: [0.78, 1.8]Random Effects Model
Secondary
Adverse and Serious Adverse Events
Assessment of number of adverse and serious adverse events by treatment group.
Time frame: 180 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Adverse and Serious Adverse Events | 45.8 percentage of participants |
| Saline Placebo | Adverse and Serious Adverse Events | 60.2 percentage of participants |
p-value: 0.001795% CI: [-0.23, -0.057]Fisher Exact
Secondary
All Cause Mortality
Time frame: 180 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | All Cause Mortality | 18.5 percentage of participants |
| Saline Placebo | All Cause Mortality | 29.1 percentage of participants |
p-value: 0.0056Log Rank
Secondary
Clot Removal (Amount of Residual Blood)
Change in blood volume measured between stability scan and end of treatment scan
Time frame: 72 hours
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Clot Removal (Amount of Residual Blood) | 0.96 odds ratio per time-weighted ml |
| Saline Placebo | Clot Removal (Amount of Residual Blood) | 0.97 odds ratio per time-weighted ml |
p-value: <0.001AUC/ Logit Model
Secondary
Functional Status - Barthel Index
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.
Time frame: 180 days
Population: All the non-missing Barthel scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Functional Status - Barthel Index | 65.2 Barthel score | Standard Deviation 37.7 |
| Saline Placebo | Functional Status - Barthel Index | 69.5 Barthel score | Standard Deviation 35.1 |
p-value: 0.312Wilcoxon (Mann-Whitney)
Secondary
Functional Status - National Institutes of Health Stroke Scale (NIHSS)
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).
Time frame: 180 days
Population: All the non-missing NIHSS scores at 180 days were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alteplase | Functional Status - National Institutes of Health Stroke Scale (NIHSS) | 3 NIHSS score |
| Saline Placebo | Functional Status - National Institutes of Health Stroke Scale (NIHSS) | 2 NIHSS score |
p-value: 0.14Wilcoxon (Mann-Whitney)
Secondary
Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 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.
Time frame: 180 days
Population: All the non-missing eGOS scores at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability | 95 % of participants with score>=4 |
| Saline Placebo | Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability | 77 % of participants with score>=4 |
p-value: 0.08795% CI: [-0.011, 0.16]Chi-squared
p-value: 0.06495% CI: [0.98, 2.43]Multivariable Logit Model
p-value: 0.33695% CI: [0.7, 2.89]Generalized Ordered Logit Model
p-value: 0.78395% CI: [0.57, 1.52]Generalized Ordered Logit Model
Secondary
Intensity of Critical Care Management - All Infections
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 180 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - All Infections | 49.8 % of participants with infections |
| Saline Placebo | Intensity of Critical Care Management - All Infections | 56.2 % of participants with infections |
p-value: 0.152Chi-squared
Secondary
Intensity of Critical Care Management - All Infections
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - All Infections | 48.2 % of participants with infections |
| Saline Placebo | Intensity of Critical Care Management - All Infections | 50.6 % of participants with infections |
p-value: 0.592Chi-squared
Secondary
Intensity of Critical Care Management - Hospital Days
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - Hospital Days | 23 Number of days |
| Saline Placebo | Intensity of Critical Care Management - Hospital Days | 24 Number of days |
p-value: 0.771Kruskal-Wallis
Secondary
Intensity of Critical Care Management - ICP Management
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - ICP Management | 9.8 Percentage of events of ICP >20mmHg |
| Saline Placebo | Intensity of Critical Care Management - ICP Management | 10.2 Percentage of events of ICP >20mmHg |
p-value: 0.45Generalized Linear Models
Secondary
Intensity of Critical Care Management - ICU Days
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - ICU Days | 14 Number of days |
| Saline Placebo | Intensity of Critical Care Management - ICU Days | 15 Number of days |
p-value: 0.098Kruskal-Wallis
Secondary
Intensity of Critical Care Management - Mechanical Ventilation
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - Mechanical Ventilation | 73.9 % of participants with ventilation |
| Saline Placebo | Intensity of Critical Care Management - Mechanical Ventilation | 76.5 % of participants with ventilation |
p-value: 0.501Chi-squared
Secondary
Intensity of Critical Care Management - Pneumonia
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - Pneumonia | 26.1 % of participants with pneumonia |
| Saline Placebo | Intensity of Critical Care Management - Pneumonia | 32.7 % of participants with pneumonia |
p-value: 0.105Chi-squared
Secondary
Intensity of Critical Care Management - Pressors
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - Pressors | 24.1 % of participants with pressors |
| Saline Placebo | Intensity of Critical Care Management - Pressors | 25.1 % of participants with pressors |
p-value: 0.795Chi-squared
Secondary
Intensity of Critical Care Management - Shunts
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Intensity of Critical Care Management - Shunts | 18.5 % of participants with shunts |
| Saline Placebo | Intensity of Critical Care Management - Shunts | 17.5 % of participants with shunts |
p-value: 0.784Chi-squared
Secondary
Predicting Hazards of Death by Treatment Group
Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.
Time frame: 180 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Predicting Hazards of Death by Treatment Group | 18.5 percentage of participants |
| Saline Placebo | Predicting Hazards of Death by Treatment Group | 29.1 percentage of participants |
p-value: 0.00695% CI: [0.41, 0.86]Cox Proportional Hazards Model
Secondary
Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)
Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals 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).
Time frame: 180 days
Population: All the non-missing EuroQol scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) | 62.8 EuroQol score | Standard Deviation 26 |
| Saline Placebo | Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) | 65.1 EuroQol score | Standard Deviation 23.3 |
p-value: 0.376t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living | 59.33 SIS score | Standard Deviation 37.9 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living | 61.19 SIS score | Standard Deviation 34.98 |
p-value: 0.634t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Communication
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Communication | 76.02 SIS score | Standard Deviation 31.47 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Communication | 79.60 SIS score | Standard Deviation 26.76 |
p-value: 0.255t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Emotion
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Emotion | 73.14 SIS score | Standard Deviation 19.62 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Emotion | 73.45 SIS score | Standard Deviation 20.24 |
p-value: 0.882t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Hand Function
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Hand Function | 53.41 SIS score | Standard Deviation 41.86 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Hand Function | 56.52 SIS score | Standard Deviation 39.69 |
p-value: 0.478t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Mobility
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Mobility | 58.30 SIS score | Standard Deviation 38.16 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Mobility | 60.10 SIS score | Standard Deviation 36.05 |
p-value: 0.65t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Participation
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Participation | 47.46 SIS score | Standard Deviation 33.01 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Participation | 49.58 SIS score | Standard Deviation 33.03 |
p-value: 0.551t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Recovery
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Recovery | 60.04 SIS score | Standard Deviation 26.42 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Recovery | 63.44 SIS score | Standard Deviation 25.44 |
p-value: 0.224t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Strength
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Strength | 54.97 SIS score | Standard Deviation 35.37 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Strength | 58.75 SIS score | Standard Deviation 34.36 |
p-value: 0.312t-test, 2 sided
Secondary
Quality of Life - Stroke Impact Scale (SIS) - Thinking
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
Time frame: 180 days
Population: All the non-missing SIS scores at 180 days were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alteplase | Quality of Life - Stroke Impact Scale (SIS) - Thinking | 58.48 SIS score | Standard Deviation 33.11 |
| Saline Placebo | Quality of Life - Stroke Impact Scale (SIS) - Thinking | 62.68 SIS score | Standard Deviation 31.18 |
p-value: 0.224t-test, 2 sided
Secondary
Safety/Mortality - Bacterial Brain Infections Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Safety/Mortality - Bacterial Brain Infections Within 30 Days | 6.8 % of participants with brain infection |
| Saline Placebo | Safety/Mortality - Bacterial Brain Infections Within 30 Days | 10.4 % of participants with brain infection |
p-value: 0.20295% CI: [-0.084, 0.014]Fisher Exact
Secondary
Safety/Mortality - Mortality Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Safety/Mortality - Mortality Within 30 Days | 8.8 Percentage of patients |
| Saline Placebo | Safety/Mortality - Mortality Within 30 Days | 14.3 Percentage of patients |
p-value: 0.05595% CI: [-0.111, 0.008]Fisher Exact
Secondary
Safety/Mortality - Systematic Bleeds Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time frame: 30 days
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Safety/Mortality - Systematic Bleeds Within 30 Days | 3.6 % of participants with systematic bleeds |
| Saline Placebo | Safety/Mortality - Systematic Bleeds Within 30 Days | 3.2 % of participants with systematic bleeds |
p-value: 0.81195% CI: [-0.028, 0.036]Fisher Exact
Secondary
Safety/Mortality - Systematic Bleeds Within 72 Hours
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
Time frame: 72 hours
Population: All patients that were enrolled in CLEAR III were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Safety/Mortality - Systematic Bleeds Within 72 Hours | 2.4 % of participants with systematic bleeds |
| Saline Placebo | Safety/Mortality - Systematic Bleeds Within 72 Hours | 2.0 % of participants with systematic bleeds |
p-value: 0.77195% CI: [-0.022, 0.03]Fisher Exact
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) | 53.6 Percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) | 52.1 Percentage of participants |
p-value: 0.77595% CI: [-0.09, 0.121]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) | 31.3 Percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) | 29.5 Percentage of participants |
p-value: 0.80895% CI: [-0.132, 0.169]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All female patients with a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) | 47.6 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) | 45.6 percentage of participants |
p-value: 0.77395% CI: [-0.113, 0.152]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All male patients with a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) | 47.6 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) | 44.3 percentage of participants |
p-value: 0.58795% CI: [-0.085, 0.151]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) | 47.3 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) | 38.5 percentage of participants |
p-value: 0.19195% CI: [-0.043, 0.218]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) | 18.5 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) | 17.9 percentage of participants |
p-value: 0.94995% CI: [-0.197, 0.211]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) | 55.1 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) | 58.3 percentage of participants |
p-value: 0.62595% CI: [-0.165, 0.099]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) | 60.6 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) | 54.7 percentage of participants |
p-value: 0.39495% CI: [-0.076, 0.194]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) | 38.8 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) | 37.4 percentage of participants |
p-value: 0.81295% CI: [-0.098, 0.126]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) | 54.4 Percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) | 48.0 Percentage of participants |
p-value: 0.4195% CI: [-0.088, 0.217]Chi-squared
Secondary
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. 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 (perfect health without symptoms) to 6 (death).
Time frame: 180 days
Population: All patients that reported they were White with a non-missing mRS score at 180 days were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alteplase | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) | 43.4 percentage of participants |
| Saline Placebo | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) | 41.8 percentage of participants |
p-value: 0.78195% CI: [-0.096, 0.128]Chi-squared