A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia



Status:Enrolling by invitation
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:1 - 21
Updated:4/4/2019
Start Date:September 27, 2018
End Date:May 31, 2019

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Evolving Treatment of Hemophilia's Impact on Neurodevelopment, Intelligence and Other Cognitive Functions (eTHINK)

The Hemophilia Growth and Development Study (HGDS) nearly 25 years ago showed haemophilia and
HIV impacted brain development, thinking, and behaviour in children and adolescents. The
eTHINK study is designed to understand whether advances in hemophilia treatment have removed
any impact of hemophilia. If there still is an impact of hemophilia, the eTHINK study will
help to identify which children or adolescents are still at risk, and how to screen other
children. Participants and their child will participate in a comprehensive assessment of
child's brain development, thinking and behavior through completing tests and questionnaires.
There is only one study visit of 1 to 1.5 hours with no follow-up required


Inclusion Criteria: - Male child or young adult (ages 1:0-3:6 and 4:0-21:11 years with
diagnosis of congenital hemophilia A or B, any severity, with or without inhibitors -
Parent able and willing to provide consent, and young adult with hemophilia (age 18-21)
able to provide consent; children (ages 7-14) and adolescents/young adults (ages 14-17)
able and willing to provide assent based upon local institutional policies - Parent able
and willing to complete neurodevelopment and cognitive parent reported scales during
comprehensive or other Hemophilia Treatment Center visit for about 45-60 minutes in English
or Spanish depending on age group) - Children, adolescents and young adults with hemophilia
(ages 1-21) able to participate in assessments of development and intelligence for about
40-45 minutes and adolescents and young adults (age 11-21) with hemophilia able and willing
to complete additional self-assessment scales for about 30-45 minutes during comprehensive
or other elective visit for in English or Spanish (depending on age group) - Provision of
informed consent before the start of any study-related activities Exclusion Criteria: -
Patient aged 3:7-3:11 years (43-47 months) - Prior participation in the study - Prior
neurocognitive screening with the same or related instruments in the prior 6 months -
Patients with hemophilia or their caregivers for whom test measures may be culturally
inappropriate - Patients with hemophilia with known history of alcohol or substance abuse -
Patients with hemophilia who have used opiates in the past 24 hours or other illicit drugs
within the past 48 hours - Patients with hemophilia currently experiencing an acute bleed
that has not resolved - Patients with hemophilia with recent head injury or concussion
within the past 4 weeks - Concurrent diagnosis of another bleeding or thrombotic disorder -
Mental incapacity, unwillingness or language barriers precluding adequate understanding or
cooperation
We found this trial at
21
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Orange, California 92868
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Atlanta, Georgia 30318
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Aurora, Colorado 80010
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Boston, Massachusetts 02115
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Charlotte, North Carolina 28277
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Chicago, Illinois 60612
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Cleveland, Ohio 44106
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Detroit, Michigan 48201
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Indianapolis, Indiana 46260
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Los Angeles, California 90027
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Minneapolis, Minnesota 55404
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70112
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Oklahoma City, Oklahoma 73112
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Omaha, Nebraska 68114
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Philadelphia, Pennsylvania 19104
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Salt Lake City, Utah 84132
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San Diego, California 92111
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Seattle, Washington 98105
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Tampa, Florida 33612
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Washington, District of Columbia 20011
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