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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01242878 |
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Date of registration:
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16/11/2010 |
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Primary sponsor: |
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Public title:
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MACS Study - Microparticles and Coagulation in Sickle Cell Disease
MACS |
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Scientific title:
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MACS Study - Microparticles and Coagulation in Sickle Cell Disease: An Observational Study to Measure the Levels of Circulating Microvesicles and Coagulation Activation Parameters in Patients With Sickle Cell Disease in the in- and Out-patient Setting. |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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360 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01242878 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Sara Trompeter, MB ChB BSC MRCPCH FRCPath |
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Address:
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Telephone:
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Email:
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sara.trompeter@nhs.net |
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Affiliation:
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Name:
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Baba Inusa, MB BS FRCPCH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Guy's and St Thomas' NHS Foundation Trust |
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Name:
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John B Porter, MB BChir FRCPath MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University College London and University College London NHS Foundation Trust |
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Name:
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Bernard A Davis, MD FRCPath |
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Address:
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Telephone:
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Email:
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Affiliation:
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Whittington Hospital NHS Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject Inclusion Criteria:
Patient (or parent if child) able to give informed consent Compound heterozygote or
homozygote for a sickling disorder (i.e. has sickle cell disease) Having a blood test in
any case
- Healthy volunteer Inclusion Criteria:
Person (or parent if child) able to give informed consent If a child, having a blood test
or cannula inserted in any case Ethnically matched - of African origin Must know their
sickle cell status or have it tested as part of the study and agree to have this result
given to them and their G.P.
Exclusion Criteria:
- Subject Exclusion Criteria:
Inability to meet all inclusion criteria
- Healthy Volunteer Exclusion Criteria:
Compound heterozygote or homozygote for a sickling disorder (i.e. has sickle cell disease)
Inability to meet all inclusion criteria Ongoing
cancerous/inflammatory/haematological/infective illness (the levels of microparticles and
coagulation parameters have been shown to be elevated in these disorders and so would not
be appropriate to be included in a control group)
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sickle Cell Disease
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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