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MACS Study - Microparticles and Coagulation in Sickle Cell Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University College, London.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
The Whittington Hospital NHS Trust
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT01242878
First received: November 16, 2010
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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
Sickle Cell Disease

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University College, London:

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


Estimated Enrollment: 360
Study Start Date: December 2010
Groups/Cohorts
healthy volunteers
ethnically matched people who do not have sickle cell disease
patients
sickle cell disease patients

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242878

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

Locations
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PJ
Whittington Hospital NHS Trust Not yet recruiting
London, United Kingdom, N19 5NF
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
  More Information

No publications provided

Responsible Party: Professor John Porter, University College London
ClinicalTrials.gov Identifier: NCT01242878     History of Changes
Other Study ID Numbers: 10/0270
Study First Received: November 16, 2010
Last Updated: November 17, 2010
Health Authority: England: National Research Ethics Service

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

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

ClinicalTrials.gov processed this record on November 27, 2014