Contact information
Type
Scientific
Primary contact
Dr Michael R. DeBaun
ORCID ID
Contact details
WUSM CB 8519
4444 Forest Park Blvd.
Saint Louis
MO
63108
United States of America
+1 314 286 1186
DeBaun_M@kids.wustl.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
U01NS42804
Study information
Scientific title
Acronym
SIT Trial
Study hypothesis
On 12/03/2008 this trial record was updated. The start date and anticipated end date of this trial were also updated from 01/04/2000 and 30/04/2005 to 01/12/2005 and 30/11/2012, respectively.
Added as of 12/03/2008:
Primary hypothesis:
1. Prophylactic blood transfusion therapy in children with silent cerebral infarcts will result in at least 86% reduction in the proportion of patients with clinically evident strokes or new or progressive silent cerebral infarcts.
Secondary hypotheses:
1. Prophylactic blood transfusion therapy will limit the further decline in general intellectual abilities when compared to the observation arm.
2. The overall benefit of blood transfusion therapy for silent cerebral infarctions outweighs the risks associated with this therapy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Sickle Cell Anemia and Stroke
Intervention
Participants will be randomly assigned to one of two groups - the blood transfusion group or the observation group. The blood transfusion group will receive regular blood transfusion therapy. All participants will receive history and physical exams every three months, cognitive testing and neurological exam annually, a TCD 12-18 months following randomization, and a final MRI of the brain at study exit. Active participation on the study is 3 years.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2005
Overall trial end date
30/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inclusion criteria amended as of 12/03/2008:
Inclusion Criteria for Screening:
1. Patient must have sickle cell anemia (hemoglobin SS or sickle B) as confirmed by the local institution by hemoglobin analysis after six months of age
2. Patient must be 5 through 14 years of age (i.e., must have attained their 5th, but not their 15th birthday when the screening consent is signed)
3. Informed consent with assent in accordance with the institutional policies
Inclusion criteria provided at time of registration:
1. Patients ages 6-12 with sickle cell anemia (Hemoglobin SS or SB)
2. Patient must have a silent cerebral infarct documented by magnetic resonance imaging (MRI) of the brain as read by the neuroradiology panel
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added as of 12/03/2008: Screen 1880; Randomize at least 204 and up to 250
Participant exclusion criteria
Exclusion criteria amended as of 12/03/2008:
Exclusion Criteria for Screening at initial screening evaluation and after informed consent has been signed as well as during the interval up to randomization:
1. Patient with a history of a focal neurologic event lasting more than 24 hours with medical documentation or a history of prior overt stroke
2. Patient with other neurological problems, such as neurofibromatosis, lead poisoning, non-febrile seizure disorder, or tuberous sclerosis
3. Patient with HIV infection
4. Pregnancy or lactating females
5. Patient who received treatment with anti-sickling drugs or hydroxyurea within 3 months or anticipate receiving anti-sickling drugs or hydroxyurea during the course of the study
6. Patients on chronic blood transfusion therapy for other reasons
7. Patient judged not likely to be compliant by his/her hematologist and study coordinator based on previous compliance in clinic appointments and following advice. Specifically, families that have missed at least two appointments without notification within 12 months prior to the trial or parents/guardians of potential patients that have been reported for medical or education neglect are not eligible for this trial
8. Patient unable to receive blood transfusion because of alloimmunization
9. Patients who have or anticipate receiving permanent (or semi-permanent) metallic structures attached to their body. (e.g., braces on teeth, body piercings), which their physicians believe will interfere with the MRI of the head to assess the presence of silent cerebral infarct
10. Patients with any person living in the same household who have been randomly assigned in the SIT Trial
Exclusion criteria provided at time of registration:
1. Patients with a history of overt stroke or focal neurological event lasting more than 24 hours
2. Patients with other neurological problems, such as neurofibromatosis, lead poisoning, or tuberous sclerosis
3. Patients with a transcranial doppler (TCD) study with a time-averaged mean velocity greater than 200 cm/sec verified by the study radiologist
Recruitment start date
01/12/2005
Recruitment end date
30/11/2012
Locations
Countries of recruitment
United States of America
Trial participating centre
WUSM CB 8519
Saint Louis, MO
63108
United States of America
Sponsor information
Organisation
National Institute of Neurological Disorders and Stroke (NINDS) (USA)
Sponsor details
Neuroscience Center
Room 2212
6001 Executive Blvd
Rockville
MD
20892
United States of America
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Neurological Disorders and Stroke (NINDS) (USA) (ref: U01NS42804)
Alternative name(s)
NINDS
Funding Body Type
private sector organisation
Funding Body Subtype
Research institutes and centers
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25140956
Publication citations
-
Results
DeBaun MR, Gordon M, McKinstry RC, Noetzel MJ, White DA, Sarnaik SA, Meier ER, Howard TH, Majumdar S, Inusa BP, Telfer PT, Kirby-Allen M, McCavit TL, Kamdem A, Airewele G, Woods GM, Berman B, Panepinto JA, Fuh BR, Kwiatkowski JL, King AA, Fixler JM, Rhodes MM, Thompson AA, Heiny ME, Redding-Lallinger RC, Kirkham FJ, Dixon N, Gonzalez CE, Kalinyak KA, Quinn CT, Strouse JJ, Miller JP, Lehmann H, Kraut MA, Ball WS, Hirtz D, Casella JF, Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia., N. Engl. J. Med., 2014, 371, 8, 699-710, doi: 10.1056/NEJMoa1401731.