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Evaluating Thromboelastography (TEG) and ETP in Sickle Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02770534
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Tracking Information
First Submitted Date May 10, 2016
First Posted Date May 12, 2016
Last Update Posted Date August 1, 2017
Study Start Date April 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2016)
results of TEG and ETP analysis:results confirming enhanced coagulation state in sickle cell patients [ Time Frame: 4 months ]
completions of analysis of all subjects and controls.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Thromboelastography (TEG) and ETP in Sickle Adults
Official Title Assessing the Utility of Thromboelastography (TEG) and Endogenous Thrombin Potential (ETP) in Adults With Sickle Cell Disease
Brief Summary The primary aim of this study is to investigate the reported enhanced coagulation status (prothrombotic status) in patients with sickle cell disease using 2 laboratory tests; thromboelastography (TEG) and Endogenous Thrombin Potential (ETP), and comparing the results to healthy race matched controls to ascertain if there is a significant difference. Race matching of the control participants is being carried out due to the well reported racial differences in coagulation parameters that exist in healthy individuals. The investigators are aiming to study the clotting state in sickle patients on regular transfusion therapy and those on hydroxycarbamide, both treatments offered to sickle patients to ameliorate the condition. The study will assess the reported prothrombotic state using TEG and ETP.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult sickle cell patients ( age 16+)attending registered and attending the service at Guys adn St Thomas Hospital.
Condition Sickle Cell Disease
Intervention Procedure: blood test
10mls extra mls of blood taken during usual phlebotomy procedures
Study Groups/Cohorts
  • Sickle patients in steady state
    Well sickle cell patients attending the outpatient clinic
    Intervention: Procedure: blood test
  • Sickle cell patients admitted in crisis
    Inpatients with acute vaso-occlusive crisis
    Intervention: Procedure: blood test
  • Sickle patients on transfusion program
    Sickle patients managed on a regualar transfusion program
    Intervention: Procedure: blood test
  • Sickle patients on Hydroxycarbamide
    Sickle cell patients managed on hydroxycarbamide and on a stable dose for at least 3 months
    Intervention: Procedure: blood test
  • Health controls
    Well age and race matched individuals without a known diagnosis of sickle cell anaemia
    Intervention: Procedure: blood test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 10, 2016)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02770534
Other Study ID Numbers GuysThomasNHS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Guy's and St Thomas' NHS Foundation Trust
Original Responsible Party Same as current
Current Study Sponsor Guy's and St Thomas' NHS Foundation Trust
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date July 2017