NCT01971463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

December 4, 2019

Completed
Last Updated

December 4, 2019

Status Verified

November 1, 2019

Enrollment Period

2.9 years

First QC Date

October 23, 2013

Results QC Date

September 30, 2019

Last Update Submit

November 14, 2019

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (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).

    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).

    contralesional hemisphere

    30 minutes after completion of saline bolus

Study Arms (1)

Normal Saline

EXPERIMENTAL

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

Other: Normal saline

Interventions

Normal salineOTHER

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

Normal Saline

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Michael Mullen
Organization
University of Pennsylvania
mmullen@pennmedicine.upenn.edu
215-662-3339

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2019

Last Updated

December 4, 2019

Results First Posted

December 4, 2019

Record last verified: 2019-11

Locations

US(1)