We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial (SIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00072761
First Posted: November 13, 2003
Last Update Posted: February 8, 2016
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:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael DeBaun, Vanderbilt University
Results First Submitted: May 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions: Sickle Cell Anemia
Stroke
Intervention: Procedure: transfusion therapy

  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
Recruitment began in December, 2004 and ended May, 2010. Among the 1074 children screened with a MRI of the brain, 1.9% (20 of 1074) had strokes and 35.2% (379 of 1074) had infarct-like lesions. 196 participants completed all pre-randomization procedures and were successfully randomly allocated.

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
Transfusion Group The transfusion group received blood transfusion therapy every 4-6 weeks for 36 months.
Observation Group The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.

Participant Flow:   Overall Study
    Transfusion Group   Observation Group
STARTED   99   97 
COMPLETED   90   95 
NOT COMPLETED   9   2 



  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
Transfusion Group The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
Observation Group The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
Total Total of all reporting groups

Baseline Measures
   Transfusion Group   Observation Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 99   97   196 
Age 
[Units: Participants]
     
<=18 years   99   97   196 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Median (Full Range)
 10 
 (5 to 15) 
 10 
 (5 to 15) 
 10 
 (5 to 15) 
Gender 
[Units: Participants]
     
Female   40   45   85 
Male   59   52   111 
Race (NIH/OMB) 
[Units: 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   91   90   181 
White   2   0   2 
More than one race   0   0   0 
Unknown or Not Reported   6   7   13 


  Outcome Measures

1.  Primary:   Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct   [ Time Frame: From study entry to study exit ]


  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
The SIT Trial results are not directly applicable to all children with SCA. Those who were on hydroxyurea therapy for severe disease, had abnormally elevated TCDs, were receiving blood transfusion for stroke prevention or had epilepsy were excluded.


  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: Michael R. DeBaun, MD, MPH
Organization: Vanderbilt University School of Medicine
phone: 615-875-3040 ext 5-3040
e-mail: m.debaun@vanderbilt.edu


Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael DeBaun, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00072761     History of Changes
Other Study ID Numbers: R01NS42804
5U01NS042804-07 ( U.S. NIH Grant/Contract )
First Submitted: November 10, 2003
First Posted: November 13, 2003
Results First Submitted: May 4, 2015
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016