Bolus of Saline in Stroke (BOSS)

November 14, 2019 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
Time Frame: 30 minutes after completion of saline bolus
contralesional hemisphere
30 minutes after completion of saline bolus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818577

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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