Ischemic StrokePhase 2BOSSNCT01971463
Bolus of Saline in Stroke
A Phase 2 study testing Normal saline in people with Ischemic Stroke, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke
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.
- Conditions
- Ischemic Stroke
- Being tested
- Normal saline
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineOther
intravenous administration of 500cc of 0.9% NaCl over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Experimental | intravenous administration of 500cc of 0.9% NaCl over 30 minutes Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes after completion of saline bolus
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
Measured: 30 minutes after completion of saline bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2016
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971463
- Sponsor's protocol ID
- 818577
- Acronym
- BOSS
- Status last verified
- Nov 2019
- First submitted
- 23 Oct 2013
- Last updated
- 4 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01971463
- Acronym / sponsor ID
- BOSS / 818577
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Posted 4 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Experimental | Other: Normal salineintravenous administration of 500cc of 0.9% NaCl over 30 minutes |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineintravenous administration of 500cc of 0.9% NaCl over 30 minutes | Other | Normal Saline |
Primary outcome
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).
Time frame: 30 minutes after completion of saline bolus
Ipsilesional hemisphere
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).
Time frame: 30 minutes after completion of saline bolus
contralesional hemisphere
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normal saline in people with Ischemic Stroke, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). (time frame: 30 minutes after completion of saline bolus). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.