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MACS Study - Microparticles and Coagulation in Sickle Cell Disease (MACS)

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ClinicalTrials.gov Identifier: NCT01242878
Recruitment Status : Unknown
Verified November 2010 by University College, London.
Recruitment status was:  Not yet recruiting
First Posted : November 17, 2010
Last Update Posted : November 18, 2010
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
The Whittington Hospital NHS Trust
Information provided by:
University College, London

Brief Summary:
Sickle cell disease (SCD) is an inherited disorder of the red blood cell. It is now the commonest genetic disorder in the UK and of childhood stroke, with up to 40% of children having a stroke (clinical or picked up on a scan) by school age. Patients are prone to develop acute crises necessitating hospital admission and resulting in long-term complications. Such events result in considerable morbidity, disability and mortality with its consequent burden on patients, families, the health service and society as a whole. Doctors have very little ability to predict who will get ill and when and so it is very difficult to known when and how to administer treatments. Furthermore there is very little in the way of treatments available and the mainstay of prevention is a chronic blood transfusion programme which is expensive, requires time off work and school and can be fraught with complications. This, in a population who is frequently educationally and socially disadvantaged at the outset. Recent evidence in sickle cell disease and other diseases that have similar underlying processes, points towards the importance of microparticles (circulating broken pieces of cells) and the coagulation system as being important. By comparing levels of these particles and molecules in patients with those found in healthy volunteers and with other measures known to be important, this study hopes to identify their role so as to improve the management of these patients and potentially to lead the way for new therapies. Participants will be required to donate a small amount of blood (1 teaspoon in the very young, two in older children and adults). The investigators aim to take this sample where possible when people are having a blood test in any case.

Condition or disease
Sickle Cell Disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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.
Study Start Date : December 2010

Resource links provided by the National Library of Medicine


Group/Cohort
healthy volunteers
ethnically matched people who do not have sickle cell disease
patients
sickle cell disease patients



Biospecimen Retention:   Samples Without DNA
plasma will be retained following appropriate informed written consent for further ethically approved studies as stipulated on the consent forms


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is an observational case-control study in adults and children with sickle cell disease. The cases are any child or adult attending the study centres with a confirmed diagnosis of sickle cell disease that meet the eligibility criteria. The controls are ethnically matched volunteers who meet the appropriate eligibility criteria for controls and who do not have sickle cell disease and will be recruited from the same study sites.
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242878


Contacts
Contact: Sara Trompeter, MB ChB BSC MRCPCH FRCPath sara.trompeter@nhs.net

Locations
United Kingdom
Whittington Hospital NHS Trust Not yet recruiting
London, United Kingdom, N19 5NF
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PJ
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
University College, London
Guy's and St Thomas' NHS Foundation Trust
The Whittington Hospital NHS Trust
Investigators
Principal Investigator: John B Porter, MB BChir FRCPath MD University College London and University College London NHS Foundation Trust
Principal Investigator: Baba Inusa, MB BS FRCPCH Guy's and St Thomas' NHS Foundation Trust
Principal Investigator: Bernard A Davis, MD FRCPath Whittington Hospital NHS Trust

Responsible Party: Professor John Porter, University College London
ClinicalTrials.gov Identifier: NCT01242878     History of Changes
Other Study ID Numbers: 10/0270
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

Keywords provided by University College, London:
HbSS
Sickle cell anemia
HbSC
HbSbetathalassemia
Hemoglobinopathy
Hemoglobinopathies

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn