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Home > "P" Clinical Trials Conditions > Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center  Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center
Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center
For Condition: Cerebrovascular Accident,Anemia, Sickle Cell,Cerebrovascular Disorders,Blood Disease
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To conduct a prospective study aimed at the early detection and treatment of cerebral vascular disease prior to irreversible brain injury in young children with sickle cell anemia (SCA).
Details: BACKGROUND: Cerebral infarction is a major contributor to childhood morbidity and mortality in sickle cell anemia (SCA) DESIGN NARRATIVE: The investigators tested the hypotheses that young children with SCA experienced a variable period of asymptomatic progressive central nervous system (CNS) vasculopathy prior to cerebral infarction; that pre-infarct CNS vasculopathy could be identified by non-invasive imaging techniques:MRI, magnetic resonance angiography (MRA), and transcranial Doppler (TCD); and that therapeutic intervention at this stage of the disease could significantly reduce the subsequent occurrence of cerebral infarction. MRI, MRA, TCD, and standardized neurologic and psychometric examinations were performed yearly in a cohort of homozygous Hb SS children enrolled at 2-4 years of age. Subjects without MRI evidence of cerebral infarction who had significant cerebral vasculopathy (cerebral arterial stenosis on MRA and/or elevated blood flow velocity on TCD) were randomized to receive either no therapy or chronic transfusion therapy, in order to determine the risk of subsequent cerebral infarction in untreated subjects with these abnormalities, and the extent to which transfusion therapy could significantly reduce the risk. Subjects with evidence of prior cerebral infarction on MRI, whether symptomatic or asymptomatic, were randomized to receive either chronic transfusion therapy alone ('standard therapy') or chronic transfusion therapy plus ticlopidine, in order to determine whether ticlopidine could significantly increase the efficacy of standard therapy in preventing recurrent cerebral infarction in SCA. Subjects with prior cerebral infarction were also offered the option of bone marrow transplantation if an HLA-identical non-SS sibling donor was available.
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DarleenPowars, , University of Southern California
Additional Information:
Study ID Numbers: 4117;
Study Start Date: April 1993
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005327
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Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center
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