CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Normal salineother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01971463
NCT01971463Phase 2Completed
CompareCT.gov

Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke

University of Pennsylvania·interventional·Posted Oct 29, 2013·Updated Dec 4, 2019

In Brief

A Phase 2 clinical trial evaluating Normal saline for Ischemic Stroke. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 29, 2013
Enrollment StartOct 1, 2013
Primary CompletionSep 1, 2016
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.7 years ago

Interventions

Normal salineother

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