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Transcranial Doppler (TCD) Ultrasound of Subjects Enrolled in BABY HUG - Ancillary to BABY HUG

This study has been completed.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: April 22, 2003
Last updated: July 23, 2008
Last verified: July 2008
To use transcranial Doppler (TCD) ultrasound to detect stroke risk in children with sickle cell disease.

Blood Disease Anemia, Sickle Cell Cerebrovascular Disorders Cerebral Embolism and Thrombosis

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:


Cerebral vasculopathy and stroke are among the most serious complications of sickle cell disease. Not every patient will develop central nervous system disease but most children have some evidence of cognitive impairment and about 10% will have overt stroke if this is not forestalled by transcranial Doppler (TCD) screening, identification of individuals at greatest risk by estimating maximal cerebral blood flow and commencing prophylactic transfusion. The basis of these recommendations is studies in children over age 2-years where stroke is most prevalent. Transfusion is not without its own serious and considerable risks so that other measures for delaying or preventing cerebral vasculopathy would be valuable. Hydroxyurea (HU) can reduce both morbidity and mortality of sickle cell anemia in adults; most likely the same pertains in children. Unknown are the effects of HU in infants and the youngest children and whether its successful use can reduce the risks of sickle cerebrovascular disease. If HU is associated with reduced TCD velocity, and if it is safe in infants, the medical implications would be high.

Baby TCD is an ancillary study to the initial phase of BABY HUG, a multicenter clinical trial funded by the NHLBI. In BABY HUG, infants (12-17 months old) with sickle cell disease (SCD) will be randomized to either hydroxyurea (HU) or placebo and followed for 24 months. There is broad interest in the effect of hydroxyurea on the central nervous system in the children being studied. Stroke occurs after age 1 year and there is evidence that the process of cerebrovascular disease starts very early in some patients. The Cooperative Study of Sickle Cell Disease documented a high risk of incident stroke in the 2-6 year age group. The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000.


The study will perform TCD on the 40 children in BABY HUG at baseline and at the end of study. TCD has proven very useful in estimation of stroke risk in children with SCD ages 2-16 years, and is at the center of a paradigm of primary stroke prevention recommended by the National Heart, Lung, and Blood Institute based on the STOP study. If stroke risk could be detected at an earlier stage (i.e., younger than the 2-16 year-old subjects in STOP), then physicians would be able to provide preventive treatment at an earlier stage of the disease. TCD will be performed before and after 24 months of treatment. TCD performance and reading will be centrally controlled and STOP-consistent. The investigators have experience in TCD of infants, the age targeted by the parent study. TCD will be compared between HU and control groups, before and after treatment. In addition, the investigators have access to data from over 400 children in the 2-4 year age range from the STOP screening program performed in the mid- to late 1990s. Since these patients were not on HU or transfusion this dataset will be used to give an estimate of the prevalence of high stroke risk without HU treatment, and can be compared to the HU group in Baby HUG, adding another important comparative dimension to the analyses. Although the sample size is purposely small as designed by the parent study, large differences in the prevalence of high-risk patients at the end of treatment could be detected by Baby TCD.


Ages Eligible for Study:   1 Year to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria
  Contacts and Locations
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Please refer to this study by its identifier: NCT00059293

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Robert Adams Augusta University
  More Information Identifier: NCT00059293     History of Changes
Other Study ID Numbers: 1208
Study First Received: April 22, 2003
Last Updated: July 23, 2008

Additional relevant MeSH terms:
Cerebrovascular Disorders
Anemia, Sickle Cell
Hematologic Diseases
Embolism and Thrombosis
Intracranial Embolism
Intracranial Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn
Thromboembolism processed this record on September 21, 2017