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A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 65 mL/h), 1.0 mL/kg/h RNS60 (up to a maximum of 130 mL/h), or 1.0 mL/kg/h (up to a maximum of 130 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.
This study is a Phase II, randomized, blinded, placebo-controlled, parallel group design. Participants experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 65 mL/h), 1.0 mL/kg/h RNS60 (up to a maximum of 130 mL/h), or 1.0 mL/kg/h (up to a maximum of 130 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy and prior to arterial closure. Outcomes of the main trial will be evaluated throughout a 90 day observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNS60 0.5 mL/kg/h | Experimental | RNS60 0.5 mL/kg/h infusion for 48h (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure) |
|
| RNS60 1.0 mL/kg/h | Experimental | RNS60 1.0 mL/kg/h infusion for 48h (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure) |
|
| Placebo 1.0 mL/kg/h | Placebo Comparator | Placebo (normal saline) 1.0 mL/kg/h infusion for 48h (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNS60 | Drug | RNS60 injection solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in a congenital anomaly/birth defect. An SAE could also be an important medical event that may not have resulted in death, was life-threatening, or required hospitalization, but jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs that started after the start of study drug infusion and are reported here. | From start of study drug administration up to Day 90 |
| Mortality: Proportion of Participants Alive at Day 90 | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-disability Based on Modified Rankin Scale (mRS ) Score at Day 90 | The mRS is a clinician-reported outcome measure for participants who have suffered a stroke. It measures functional recovery as the degree of disability or dependence in daily activities in a 6-point disability scale with possible scores ranging from 0 to 5: 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, requiring constant nursing care and attention. A score of 6 is used for participants who expire (death). Non-disability was defined as a score ranging from 0 to 2. Disability was defined as a score ranging from 3-6. |
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Inclusion Criteria:
Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
Age 18 years or older.
Onset (last-known-well) time to randomization time within 24 hours.
Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
Pre-stroke (24 hours prior to stroke onset) historical modified Rankin Scale (mRS) ≤2. Patient must be living independently without requiring nursing care.
Qualifying imaging performed less than 2 hours prior to randomization.
Consent process completed as per applicable laws and regulation and the IRB requirements.
Exclusion Criteria:
Evidence of a large core of established infarction defined as Alberta Stroke Program Early Computerized Tomography Score (ASPECTS) 0-4.
Evidence of absence of collateral circulation on qualifying imaging (collateral score of 0 or 1 if multiphase computed tomography angiography (mCTA) is used, or absence of adequate ischemic penumbra in the judgment of the Investigator if computed tomographic perfusion (CTP) is used).
Any evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.
Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.
Endovascular thrombectomy procedure is completed as defined by the presence of arterial access closure.
Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
Estimated or known weight > 130 kg (287 lbs).
Known pregnant/lactating female.
Myocardial infarction (MI) within 6 months prior to Screening including non-Q wave MI; Diagnosis of congestive heart failure (CHF) with either:
Known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).
Inability to have magnetic resonance imaging (MRI) (Non-magnetic resonance [MR] compatible implants or any other foreseeable reason, including claustrophobia)
Severe or fatal comorbid illness that will prevent improvement or follow up.
Inability to complete follow-up treatment to Day 90.
Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.
Reported known seizure at time of stroke onset.
Ischemic stroke within previous 30 days.
Patients in normal sinus rhythm with a known QTcF > 460 ms at Screening.
Any other symptom that in the investigator's opinion may complicate or preclude the subject from participating in this trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Oregon Health & Science University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40671649 | Result | Ghosh S, Dubow JS, Sutherland J, Smith W, Chiu D, Clark WM, Favilla CG, Ansari SA, Kalmes A, Mock J, Cook DJ, Madsen TE, Jayaraman M, Moldovan K, Torabi R, Liebeskind DS, Fisher M, McTaggart RA. Randomized, Proof-of-Concept Trial (RESCUE) of RNS60 as an Adjunct Therapy in Acute Ischemic Stroke. Stroke. 2025 Sep;56(9):2386-2397. doi: 10.1161/STROKEAHA.125.051179. Epub 2025 Jul 17. | |
| 42088332 |
| Label | URL |
|---|---|
| Related Info | View source |
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Participants experiencing a large vessel occlusion (LVO) acute ischemic stroke (AIS) who were selected for endovascular thrombectomy (EVT) were randomized in a 1:1:1 ratio to one of three arms in the study. Participants were given a 48-hour infusion of either 0.5 milliliter/kilogram/hour (mL/kg/h) RNS60, 1.0 mL/kg/h RNS60, or 1.0 mL/kg/h placebo (normal saline).
This study was conducted at 5 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | RNS60 1.0 mL/kg/h | Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| FG001 | RNS60 0.5 mL/kg/h | Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| FG002 | Placebo 1.0 mL/kg/h | Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT Population: All randomized participants who received study drug regardless of treatment actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | RNS60 1.0 mL/kg/h | Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| BG001 | RNS60 0.5 mL/kg/h |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in a congenital anomaly/birth defect. An SAE could also be an important medical event that may not have resulted in death, was life-threatening, or required hospitalization, but jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs that started after the start of study drug infusion and are reported here. | Safety Population: All randomized participants who received any volume of study drug based on the actual treatment received. | Posted | Count of Participants | Participants | From start of study drug administration up to Day 90 |
|
From the start of study drug administration up to Day 90
Treatment-emergent AEs were defined as AEs that started after the start of study drug infusion and are reported here. Safety Population: All randomized participants who received any volume of study drug based on the actual treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RNS60 1.0 mL/kg/h | Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke in evolution | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Revalesio Corporation | 253-922-2600 | contact@revalesio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2022 | Dec 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2023 | Dec 18, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000627108 | RNS60 |
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| Placebo |
| Drug |
Placebo injection solution |
|
| Day 90 |
| Change From Baseline in Infarct Volume of Stroke at 48 Hours | Infarct progression/regression was measured by Magnetic Resonance Imaging (MRI) of the brain. The mean change from post-EVT baseline in the volume of injured tissue was calculated at 48 hours. | Baseline, 48 hours |
| National Institutes of Health Stroke Scale (NIHSS) at 24 Hours | The NIHSS is a standardized neurological examination scale that is a measure of disability and recovery after acute stroke. The NIHSS assessment is a standardized 15-item impairment scale intended to evaluate neurologic outcome and degrees of recovery for subjects with stroke. The scale assesses levels of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect). The NIHSS was scored by those trained in the use of this scale. Each item was scored in ranges 0-2, 0-3, or 0-4. A score of 0 indicates normal performance. Total scores on the NIHSS ranged from 0-42, with higher values reflecting increasing severity. Stroke severity was further stratified in the following way: > 25: Very severe; 15-24: Severe; 5-14: Mild to moderately severe; < 5: Mild. | 24 hours |
| Proportion of Participants With Worsening of Stroke | Worsening of stroke was defined as progression, or hemorrhagic transformation of the index stroke, as documented by brain imaging, which is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥ 4-point increase from lowest NIHSS pre-decline and/or (c) results in death. Proportion of participants with worsening of stroke was calculated as number of participants with worsening of stroke divided by the total number of participants observed over the 90-day period in each arm. | Up to Day 90 |
| Percentage of Participants With Barthel Index (BI) Score ≥95 at Day 90 | The BI is an index of functional independence. Its values range from 0 to 100, with higher scores indicating greater independence. Score range in BI items: Feeding 0-10; Bathing 0-5; Grooming 0-5; Dressing 0-10; Bowels 0-10; Bladder 0-10; Toilet use 0-10; Transfers (bed to chair and back) 0-15; Mobility (on level surfaces) 0-15; Stairs 0-10. Item scores vary in increments of 5 points. Functional independence at Day 90 was evaluated. Participants having a score ≥95 on the BI Score were deemed to have achieved functional independence, whereas those scoring <95 at Day 90 were deemed to have failed to achieve functional independence. | Day 90 |
| Health-related Quality of Life as Measured by 5-Level EuroQoL 5D Index (EQ-5D-5L) at Day 90 | EQ-5D-5L is a generic instrument for measuring health-related quality of life. It consists of a 5-item questionnaire, which was interviewer administered by study staff. The 5-item questionnaire comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 response levels (1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems, 5-unable to/extreme problems). The health state is then summarized to be a single number, EQ-5D-5L Index score, by applying a country-specific standard value set. EQ-5D-5L Index score for the United States ranges from -0.59 to 1, where 1 indicates a better health condition. | Day 90 |
| Portland |
| Oregon |
| 97239 |
| United States |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Chattanooga Center for Neurologic Research | Chattanooga | Tennessee | 37404 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Derived |
| Ghosh S, Dubow J, Favilla CG, Sutherland J, Kalmes A, Mock J, Chiu D, Clark WM, Ansari SA, Nicodemus-Johnson J, Anderson L, Liebeskind DS, Fisher M, McTaggart RA. RNS60 RESCUE Trial in Acute Ischemic Stroke: Post Hoc Analysis in Participants Enrolled <12 Hours Since Last Known Well. Stroke Vasc Interv Neurol. 2026 Apr 9;6(3):e002196. doi: 10.1161/SVIN.125.002196. eCollection 2026 May. |
| Physician Decision |
|
| Withdrawal by Legal Authorized Representative |
|
| Withdrawal by Subject |
|
Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
| BG002 | Placebo 1.0 mL/kg/h | Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
|
Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| OG001 | RNS60 0.5 mL/kg/h | Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
| OG002 | Placebo 1.0 mL/kg/h | Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). |
|
|
| Primary | Mortality: Proportion of Participants Alive at Day 90 | ITT Population: All randomized participants who received study drug regardless of treatment actually received. | Posted | Number | proportion of participants | Day 90 |
|
|
|
| Secondary | Number of Participants With Non-disability Based on Modified Rankin Scale (mRS ) Score at Day 90 | The mRS is a clinician-reported outcome measure for participants who have suffered a stroke. It measures functional recovery as the degree of disability or dependence in daily activities in a 6-point disability scale with possible scores ranging from 0 to 5: 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, requiring constant nursing care and attention. A score of 6 is used for participants who expire (death). Non-disability was defined as a score ranging from 0 to 2. Disability was defined as a score ranging from 3-6. | ITT Population: All randomized participants who received study drug regardless of treatment actually received. | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| Secondary | Change From Baseline in Infarct Volume of Stroke at 48 Hours | Infarct progression/regression was measured by Magnetic Resonance Imaging (MRI) of the brain. The mean change from post-EVT baseline in the volume of injured tissue was calculated at 48 hours. | ITT Population: All randomized participants who received study drug regardless of treatment actually received. Number of participants analyzed is the number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mL | Baseline, 48 hours |
|
|
|
| Secondary | National Institutes of Health Stroke Scale (NIHSS) at 24 Hours | The NIHSS is a standardized neurological examination scale that is a measure of disability and recovery after acute stroke. The NIHSS assessment is a standardized 15-item impairment scale intended to evaluate neurologic outcome and degrees of recovery for subjects with stroke. The scale assesses levels of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect). The NIHSS was scored by those trained in the use of this scale. Each item was scored in ranges 0-2, 0-3, or 0-4. A score of 0 indicates normal performance. Total scores on the NIHSS ranged from 0-42, with higher values reflecting increasing severity. Stroke severity was further stratified in the following way: > 25: Very severe; 15-24: Severe; 5-14: Mild to moderately severe; < 5: Mild. | ITT Population: All randomized participants who received study drug regardless of treatment actually received. The number of participants analyzed is the number of participants with data available at the 24 hour time point. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| Secondary | Proportion of Participants With Worsening of Stroke | Worsening of stroke was defined as progression, or hemorrhagic transformation of the index stroke, as documented by brain imaging, which is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥ 4-point increase from lowest NIHSS pre-decline and/or (c) results in death. Proportion of participants with worsening of stroke was calculated as number of participants with worsening of stroke divided by the total number of participants observed over the 90-day period in each arm. | ITT Population: All randomized participants who received study drug regardless of treatment actually received. | Posted | Number | proportion of participants | Up to Day 90 |
|
|
|
| Secondary | Percentage of Participants With Barthel Index (BI) Score ≥95 at Day 90 | The BI is an index of functional independence. Its values range from 0 to 100, with higher scores indicating greater independence. Score range in BI items: Feeding 0-10; Bathing 0-5; Grooming 0-5; Dressing 0-10; Bowels 0-10; Bladder 0-10; Toilet use 0-10; Transfers (bed to chair and back) 0-15; Mobility (on level surfaces) 0-15; Stairs 0-10. Item scores vary in increments of 5 points. Functional independence at Day 90 was evaluated. Participants having a score ≥95 on the BI Score were deemed to have achieved functional independence, whereas those scoring <95 at Day 90 were deemed to have failed to achieve functional independence. | Posted | Number | percentage of participants | Day 90 |
|
|
|
| Secondary | Health-related Quality of Life as Measured by 5-Level EuroQoL 5D Index (EQ-5D-5L) at Day 90 | EQ-5D-5L is a generic instrument for measuring health-related quality of life. It consists of a 5-item questionnaire, which was interviewer administered by study staff. The 5-item questionnaire comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 response levels (1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems, 5-unable to/extreme problems). The health state is then summarized to be a single number, EQ-5D-5L Index score, by applying a country-specific standard value set. EQ-5D-5L Index score for the United States ranges from -0.59 to 1, where 1 indicates a better health condition. | ITT Population: All randomized participants who received study drug regardless of treatment actually received. Number of participants analyzed is the number of participants with available data on Day 90. | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
|
|
|
| 2 |
| 24 |
| 6 |
| 24 |
| 21 |
| 24 |
| EG001 | RNS60 0.5 mL/kg/h | Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure). | 2 | 30 | 10 | 30 | 28 | 30 |
| EG002 | Placebo 1.0 mL/kg/h | Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure). | 4 | 28 | 8 | 28 | 27 | 28 |
| Brain edema | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hemorrhagic transformation stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bacteremia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Klebsiella bacteremia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hemorrhagic transformation stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Stroke in evolution | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Brain edema | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Brain compression | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral mass effect | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hemorrhagic cerebral infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrostomy | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
The investigator can publish only a) after first publication of the data by the sponsor or b) 18 months after the study has been completed, whichever comes first. The sponsor can review results communications 30 days prior to public release and can delay these for no more than 60 days from the date that the request is given to the investigator. The sponsor cannot require changes to the communication, other than to remove sponsor confidential information, and cannot unilaterally extend the delay.
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Change From Baseline at 48 Hours |
|
|