- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02770534
Evaluating Thromboelastography (TEG) and ETP in Sickle Adults
Assessing the Utility of Thromboelastography (TEG) and Endogenous Thrombin Potential (ETP) in Adults With Sickle Cell Disease
Study Overview
Detailed Description
Sickel cell disease (SCD) is the most common inherited red cell disorder worldwide, the genetic mutation in SCD results in the production of abnormal haemoglobin (HbS). This leads to anaemia and unpredictable painful episodes referred to as a sickle cell crisis. Sickle cell crises result in significant chronic health problems including stroke, kidney failure, breathing problems, leg ulcers and chronic and ultimately leads to a decrease in life expectancy.
The method by which sickling results in the above issues is recognised as very complex and it is thought these patients may have enhanced blood clotting which may play a role in the complications they get. Sickle cell patients are reported to have higher risk of blood clots such as deep vein thrombosis.
The primary aim in this study is to investigate the reported enhanced coagulation status in sickle cell adult sickle cell patients using 2 laboratory tests, thromboelastography (TEG) and Endogenous Thrombin Potential (ETP) , the investigators will compare the results in sickle participants to healthy race matched control participants to show if there is a significant difference. The investigators also aim to study the coagulation status in sickle participants on a variety of treatments such as transfusion and hydroxycarbamide, both treatments offered to sickle patients. Many trials have shown the benefits of both transfusions and hydroxycarbamide in SCD, they reduce the risk of stroke and frequency with which patients get crises.
To the best of teh investigators knowledge this will be the first study evaluating the clinical utility of TEG and ETP in adult patients with SCD
The trial will be conducted in compliance with the principles of the Declaration of Helsinki and the principles of Good Clinical Practice. It has been submitted for approval to the London NHS Research Ethics Committee.
Trial Design & Flowchart This is a cross sectional case controlled clinical study in patients with sickle cell disease. Control participants will be race and age matched participants without sickle cell disease. Written informed consent will be obtained from all participants. The samples will be taken as part of the usual clinic or inpatient procedure with 10 extra millilitres of blood venesected at a phlebotomist or nurse scheduled to venesect participants as part of their usual medical care. Healthy controls will be asked to provide a 10ml blood sample which will be taken by a qualified member of staff. The investigators are aiming to collect samples from 100 patients in total and 20 healthy controls for comparison
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, SE1
- Guys and St Thomas Nhs Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: Patient participants must be over 16 years of age with sickle disease HbSS or HbSb0, SCD genotype which must have been previously confirmed by high performance liquid chromatography with results on GSTT trust electronic patient record (EPR), all participants must be able to give written consent.
Exclusion Criteria:
currently pregnant have a known diagnosis of an inherited bleeding disorder such as e.g. von willebrand disease on anticoagulant therapy, have severe liver disease with liver transaminases greater than 5x upper limit of normal.
Healthy control paticipants will be race and age matched to the patient cohort and must also not be currently pregnant, have a known diagnosis of an inherited bleeding disorder such as e.g. von willebrand disease. The investigators will also exclude healthy participants on anticoagulant therapy as well as those with severe liver disease and liver transaminases greater than 5x upper limit of normal.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Sickle patients in steady state
Well sickle cell patients attending the outpatient clinic
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10mls extra mls of blood taken during usual phlebotomy procedures
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Sickle cell patients admitted in crisis
Inpatients with acute vaso-occlusive crisis
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10mls extra mls of blood taken during usual phlebotomy procedures
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Sickle patients on transfusion program
Sickle patients managed on a regualar transfusion program
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10mls extra mls of blood taken during usual phlebotomy procedures
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Sickle patients on Hydroxycarbamide
Sickle cell patients managed on hydroxycarbamide and on a stable dose for at least 3 months
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10mls extra mls of blood taken during usual phlebotomy procedures
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Health controls
Well age and race matched individuals without a known diagnosis of sickle cell anaemia
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10mls extra mls of blood taken during usual phlebotomy procedures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
results of TEG and ETP analysis:results confirming enhanced coagulation state in sickle cell patients
Time Frame: 4 months
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completions of analysis of all subjects and controls.
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4 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuysThomasNHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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