Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-06-25 @ 1:35 AM
Study NCT ID:
NCT02770534
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Thromboelastography (TEG) and ETP in Sickle Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-02-09', 'releaseDate': '2017-08-03'}], 'estimatedResultsFirstSubmitDate': '2017-08-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'results of TEG and ETP analysis:results confirming enhanced coagulation state in sickle cell patients', 'timeFrame': '4 months', 'description': 'completions of analysis of all subjects and controls.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nTo 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\n\nThe 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.\n\nTrial 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult sickle cell patients ( age 16+)attending registered and attending the service at Guys adn St Thomas Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': '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.\n\nExclusion Criteria:\n\ncurrently 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.\n\nHealthy 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.'}, 'identificationModule': {'nctId': 'NCT02770534', 'briefTitle': 'Evaluating Thromboelastography (TEG) and ETP in Sickle Adults', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Assessing the Utility of Thromboelastography (TEG) and Endogenous Thrombin Potential (ETP) in Adults With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'GuysThomasNHS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sickle patients in steady state', 'description': 'Well sickle cell patients attending the outpatient clinic', 'interventionNames': ['Procedure: blood test']}, {'label': 'Sickle cell patients admitted in crisis', 'description': 'Inpatients with acute vaso-occlusive crisis', 'interventionNames': ['Procedure: blood test']}, {'label': 'Sickle patients on transfusion program', 'description': 'Sickle patients managed on a regualar transfusion program', 'interventionNames': ['Procedure: blood test']}, {'label': 'Sickle patients on Hydroxycarbamide', 'description': 'Sickle cell patients managed on hydroxycarbamide and on a stable dose for at least 3 months', 'interventionNames': ['Procedure: blood test']}, {'label': 'Health controls', 'description': 'Well age and race matched individuals without a known diagnosis of sickle cell anaemia', 'interventionNames': ['Procedure: blood test']}], 'interventions': [{'name': 'blood test', 'type': 'PROCEDURE', 'description': '10mls extra mls of blood taken during usual phlebotomy procedures', 'armGroupLabels': ['Health controls', 'Sickle cell patients admitted in crisis', 'Sickle patients in steady state', 'Sickle patients on Hydroxycarbamide', 'Sickle patients on transfusion program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Guys and St Thomas NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-08-03', 'type': 'RELEASE'}, {'date': '2018-02-09', 'type': 'RESET'}], 'unpostedResponsibleParty': "Guy's and St Thomas' NHS Foundation Trust"}}}}