We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety of Intravenous Thrombolytics in Stroke on Awakening (SAIL-ON)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643902
First Posted: July 18, 2012
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Victor C Urrutia, MD, Johns Hopkins University
Results First Submitted: January 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stroke
Intervention: Drug: tPA

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IV tPA

Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria

rt-PA: IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival.


Participant Flow:   Overall Study
    IV tPA
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IV tPA

Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria

IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.


Baseline Measures
   IV tPA 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      9  45.0% 
>=65 years      11  55.0% 
Age 
[Units: Years]
Mean (Full Range)
 65 
 (47 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  40.0% 
Male      12  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      20 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      10  50.0% 
White      10  50.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment   [ Time Frame: within 36 hours of treatment ]

2.  Secondary:   Functional Outcome by the Modified Rankin Scale at 90 Days   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Victor C. Urrutia
Organization: Johns Hopkins University School of Medicine
phone: 410-955-2228
e-mail: vurruti1@jhmi.edu



Responsible Party: Victor C Urrutia, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01643902     History of Changes
Other Study ID Numbers: ML28242
First Submitted: July 16, 2012
First Posted: July 18, 2012
Results First Submitted: January 19, 2016
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017