Sickle Cell DiseaseNCT02770534
Evaluating Thromboelastography (TEG) and ETP in Sickle Adults
An observational study of Sickle Cell Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- blood test
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult sickle cell patients ( age 16+)attending registered and attending the service at Guys adn St Thomas Hospital.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas NHS Foundation Trust
London, SE1
About this study
Official title: Assessing the Utility of Thromboelastography (TEG) and Endogenous Thrombin Potential (ETP) in Adults With Sickle Cell Disease
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.
Read the 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
- Conditions
- Sickle Cell Disease
- Being tested
- blood test
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testProcedure or surgery
10mls extra mls of blood taken during usual phlebotomy procedures
| Study group | Role | What they receive |
|---|---|---|
| Sickle patients in steady state | Well sickle cell patients attending the outpatient clinic Receives: Procedure: blood test | |
| Sickle cell patients admitted in crisis | Inpatients with acute vaso-occlusive crisis Receives: Procedure: blood test | |
| Sickle patients on transfusion program | Sickle patients managed on a regualar transfusion program Receives: Procedure: blood test | |
| Sickle patients on Hydroxycarbamide | Sickle cell patients managed on hydroxycarbamide and on a stable dose for at least 3 months Receives: Procedure: blood test | |
| Health controls | Well age and race matched individuals without a known diagnosis of sickle cell anaemia Receives: Procedure: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
results of TEG and ETP analysis:results confirming enhanced coagulation state in sickle cell patients
completions of analysis of all subjects and controls.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770534
- Sponsor's protocol ID
- GuysThomasNHS
- Status last verified
- Jul 2017
- First submitted
- 10 May 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Utility of Thromboelastography (TEG) and Endogenous Thrombin Potential (ETP) in Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02770534
- Acronym / sponsor ID
- GuysThomasNHS
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sickle patients in steady state | – | Procedure: blood testWell sickle cell patients attending the outpatient clinic |
| Sickle cell patients admitted in crisis | – | Procedure: blood testInpatients with acute vaso-occlusive crisis |
| Sickle patients on transfusion program | – | Procedure: blood testSickle patients managed on a regualar transfusion program |
| Sickle patients on Hydroxycarbamide | – | Procedure: blood testSickle cell patients managed on hydroxycarbamide and on a stable dose for at least 3 months |
| Health controls | – | Procedure: blood testWell age and race matched individuals without a known diagnosis of sickle cell anaemia |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult sickle cell patients ( age 16+)attending registered and attending the service at Guys adn St Thomas Hospital.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood test10mls extra mls of blood taken during usual phlebotomy procedures | Procedure or surgery | Health controls, Sickle cell patients admitted in crisis, Sickle patients in steady state, Sickle patients on Hydroxycarbamide, Sickle patients on transfusion program |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Disease
Active, not recruitingObservational study
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
Sickle Cell Anemia, Sickle Cell Thalassemia
Enrolling by invitationPhase 4
A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
Pyruvate Kinase Deficiency, Anemia, Hemolytic
Active, not recruitingPhase 2
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
Sickle Cell Disease
RecruitingPhase 1/2
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results of TEG and ETP analysis:results confirming enhanced coagulation state in sickle cell patients (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.