Silent Cerebral Infarct Multi-Center Clinical Trial
| ISRCTN | ISRCTN52713285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52713285 |
| Secondary identifying numbers | U01NS42804 |
- Submission date
- 24/08/2004
- Registration date
- 11/10/2004
- Last edited
- 21/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael R. DeBaun
Scientific
Scientific
WUSM CB 8519
4444 Forest Park Blvd.
Saint Louis, MO
63108
United States of America
| Phone | +1 314 286 1186 |
|---|---|
| DeBaun_M@kids.wustl.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SIT Trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2005 |
| Completion date | 30/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Added as of 12/03/2008: Screen 1880; Randomize at least 204 and up to 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 30/11/2012 |
Locations
Countries of recruitment
- United States of America
Study participating centre
WUSM CB 8519
Saint Louis, MO
63108
United States of America
63108
United States of America
Sponsor information
National Institute of Neurological Disorders and Stroke (NINDS) (USA)
Government
Government
Neuroscience Center, Room 2212
6001 Executive Blvd
Rockville, MD
20892
United States of America
| Website | http://www.ninds.nih.gov/ |
|---|---|
"ROR" |
https://ror.org/01s5ya894 |
Funders
Funder type
Government
National Institute of Neurological Disorders and Stroke (NINDS) (USA) (ref: U01NS42804)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute of Neurological Disorders & Stroke, NIH/National Institute of Neurological Disorders and Stroke, NIH National Institute of Neurological Disorders and Stroke, Instituto Nacional de Trastornos Neurológicos y Accidentes Cerebrovasculares, The National Institute of Neurological Disorders and Stroke, National Institute of Neurological Disorders and Blindness, National Institute of Neurological and Communicative Disorders and Stroke, NINDS, NINDB, NINCDS
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/08/2014 | Yes | No |
