Trial Outcomes & Findings for Bolus of Saline in Stroke (NCT NCT01971463)

NCT ID: NCT01971463

Last Updated: 2019-12-04

Results Overview

Ipsilesional hemisphere

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: 30 minutes after completion of saline bolus
• Results posted on: 2019-12-04

Participant Flow

Participant milestones

Measure	Normal Saline intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Overall Study STARTED	81
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bolus of Saline in Stroke

Baseline characteristics by cohort

Measure	Normal Saline n=57 Participants intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Time from symptom onset	66 hours n=5 Participants
NIH Stroke Scale	2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after completion of saline bolus

Ipsilesional hemisphere

Outcome measures

Measure	Normal Saline n=57 Participants intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).	17 percent change from baseline flow Interval -2.0 to 43.1

PRIMARY outcome

Timeframe: 30 minutes after completion of saline bolus

contralesional hemisphere

Outcome measures

Measure	Normal Saline n=57 Participants intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes
The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).	13.3 percent change from baseline flow Interval -4.3 to 36.0

Adverse Events

Normal Saline

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Normal Saline n=81 participants at risk intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Vascular disorders IV infiltration	1.2% 1/81 • Number of events 1
Cardiac disorders Elevated systolic blood pressure	1.2% 1/81 • Number of events 1
Cardiac disorders Tachycardia	1.2% 1/81 • Number of events 1

Additional Information

Michael Mullen

University of Pennsylvania

Phone: 215-662-3339

Email: mmullen@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place