Completed

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

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What is being collected

Data Collection

Who is being recruted

Anemia+13

+ Anemia, Hemolytic

+ Anemia, Hemolytic, Congenital

Until 100 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: April 1993
See protocol details

Summary

Principal SponsorUniversity of Southern California
Last updated: July 5, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00005327
Principal SponsorUniversity of Southern California
Last updated: July 5, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Until 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, HemolyticAnemia, Hemolytic, CongenitalBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesVascular DiseasesGenetic Diseases, InbornAnemia, Sickle CellCerebrovascular DisordersHematologic DiseasesStroke

Criteria

No eligibility criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers