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Bolus of Saline in Stroke (BOSS)

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Normal saline
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ischemic Stroke

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Normal Saline

Arm Description

intravenous administration of 500cc of 0.9% NaCl over 30 minutes

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 23, 2013
Last Updated
November 14, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01971463
Brief Title
Bolus of Saline in Stroke
Acronym
BOSS
Official Title
Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Experimental
Arm Description
intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Primary Outcome Measure Information:
Title
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).
Description
Ipsilesional hemisphere
Time Frame
30 minutes after completion of saline bolus
Title
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).
Description
contralesional hemisphere
Time Frame
30 minutes after completion of saline bolus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Bolus of Saline in Stroke

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