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Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00005327
First received: May 25, 2000
Last updated: January 15, 2016
Last verified: August 2004

May 25, 2000
January 15, 2016
April 1993
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Complete list of historical versions of study NCT00005327 on ClinicalTrials.gov Archive Site
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Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center
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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).

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.

Observational
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  • Anemia, Sickle Cell
  • Blood Disease
  • Cerebrovascular Disorders
  • Cerebrovascular Accident
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 1998
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No eligibility criteria
Male
up to 100 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00005327
4117, P60HL048484
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University of Southern California
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: Darleen Powars University of Southern California
University of Southern California
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP