Ischemic Stroke
Conditions
Brief summary
This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke within 96 hours of enrollment. The study intervention will be a one hour monitoring session. There will be a 15 minute baseline measurement period, followed by intravenous administration of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All study measurements will cease after 1 hour. Subjects will be followed during their hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse events and to collect clinical information.
Interventions
OTHERNormal saline
intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery territory on either side of the brain * Study intervention can be initiated within 96 hours of symptom onset * Willingness and ability to sign informed consent by patient or legally acceptable surrogate decision-maker
Exclusion criteria
* Infarct limited to the brainstem and/or cerebellum with no involvement of the cerebral hemispheres * Bi-hemispheric infarction or acute infarct in the contra-lateral hemisphere within the past 30 days * Symptoms of active congestive heart failure (dyspnea, orthopnea, increased oxygen requirement) * Exacerbation of congestive heart failure, requiring hospitalization, within the past 30 days or severe systolic dysfunction with a known ejection fraction \<20% * End stage renal disease requiring hemodialysis or a creatinine clearance \<20 ml/min/1.73 m2 * Hemicraniectomy or other skull defect that would interfere with monitoring * Pregnant women are excluded. Women of child-bearing age must have a negative pregnancy test prior to enrollment * Participation in another clinical trial * Any other illness or condition that the investigator feels would pose a hazard to the subject from participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | 30 minutes after completion of saline bolus | Ipsilesional hemisphere |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | Normal Saline |
|---|---|
| Age, Continuous | 61 years |
| NIH Stroke Scale | 2 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 31 Participants |
| Time from symptom onset | 66 hours |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 3 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).
Ipsilesional hemisphere
Time frame: 30 minutes after completion of saline bolus
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normal Saline | The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | 17 percent change from baseline flow |
Primary
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).
contralesional hemisphere
Time frame: 30 minutes after completion of saline bolus
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normal Saline | The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | 13.3 percent change from baseline flow |
Comparison: Change in oCBF from baseline to post-bolus, ipsilesional hemispherep-value: <0.05Wilcoxon signed rank
p-value: <0.00195% CI: [0.03, 0.07]Mixed Models Analysis