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Bolus of Saline in Stroke (BOSS)

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ClinicalTrials.gov Identifier: NCT01971463
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Other: Normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke
Study Start Date : October 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal Saline
intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Other: Normal saline
intravenous administration of 500cc of 0.9% NaCl over 30 minutes




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971463


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01971463    
Other Study ID Numbers: 818577
First Posted: October 29, 2013    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: December 4, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases