Sickle Cell DiseaseNCT02565082
Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients
A study testing Blood sampling - healthy volunteers, Blood sampling - sickle cell patients arm - stable condition and Blood sampling - sickle cell patients arm- exsanguinotransfusion needed in people with Sickle Cell Disease, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid sequence of the β chain of hemoglobin. The most expressive and most frequent complication of the disease is vaso-occlusive crisis, dominated by a painful syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Blood sampling - healthy volunteers, Blood sampling - sickle cell patients arm - stable condition and Blood sampling - sickle cell patients arm- exsanguinotransfusion needed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Jul 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sickle cell disease group: Sickle cell disease patients aged over 18 years
- Healthy volunteers group: Healthy volunteers, age matching with the sickle cell disease group
Who cannot join
- Sickle cell disease group: Pregnant women, dialysis patients, patients with an hepatic impairment, patients under treatments that can interfere with coagulation
- Healthy volunteers group: Pregnant women, known chronical disease, acute inflammatory syndrome, hemostasis disorder, abnormal complete blood count
Trial locations and contacts
1 site in 1 country.
About this study
Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid sequence of the β chain of hemoglobin.
The most expressive and most frequent complication of the disease is vaso-occlusive crisis, dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic biological disturbances are observed in sickle cell patients.Sickle cell disease is considered nowadays as a hypercoagulable state.
Read more
However, the approach used so far to the measure of clotting in sickle cell disease was segmented in the sense that the various components of the hemostatic balance were studied separately.The thrombin generation test is a functional test which explores the coagulation globally, integrating both pro players that anticoagulants actors in the system. The investigators already used this test to demonstrate that the hemostatic potential was high in a cohort of affected children compared to control children of the same age.
This test will be used to characterize the hemostatic potential of adult sickle cell patients followed at the CHU Brugmann Hospital.
Read the detailed description
Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid sequence of the β chain of hemoglobin. This is the most common genetic disease in the world. The majority of patients are in Sub-Saharan Africa; however, the increase in migratory movements of populations helps to move patients out of the initial zones of the disease.
According to recent data, about 400 patients would be followed in the Belgian hospitals, and about 1 in 1500 newborns in Belgium would be a major carrier of hemoglobinopathies. The most expressive and most frequent complication of the disease is vaso-occlusive crisis, dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic biological disturbances are observed in sickle cell patients. Their contribution to the course of the disease is becoming increasingly stressing. Among them are intravascular hemolysis, hyper-adhesion of blood cells to vascular endothelium, inflammation, oxidative stress, vasculopathy and bleeding disorders.
Sickle cell disease is considered nowadays as a hypercoagulable state. Indeed, sickle cell patients have a high risk of non-hemorrhagic stroke, thrombosis in the pulmonary arteries and deep vein thrombosis that are otherwise associated with mortality and high morbidity. Many anomalies at various levels in the hemostatic system demonstrate coagulation activation even in clinically stable condition.
However, the approach used so far to the measure of clotting in sickle cell disease was segmented in the sense that the various components of the hemostatic balance were studied separately. This scale is complex, this approach difficult to give a comprehensive and integrated picture of the various disturbances in the system. The thrombin generation test is a functional test which explores the coagulation globally, integrating both pro players that anticoagulants actors in the system. The investigators have used this test to demonstrate that the hemostatic potential was high in a cohort of affected children compared to control children of the same age. In this cohort high hemostatic potential was related to the rate of circulating microparticles and intravascular hemolysis rate. Studies are underway to look for correlations between the hemostatic potential and clinical complications in this pediatric cohort.
The use of thrombin generation test for the study of hemostasis in adult patients with sickle cell disease, and the contribution of coagulation disorders with the occurrence of complications of the disease remain little known. The investigators will therefore:
- Characterize the hemostatic potential of adult sickle cell patients followed at the CHU Brugmann
- Search for links between the hemostatic potential and other biological phenomena observed during the disease (intravascular hemolysis, microparticles, vasculopathy, inflammation)
- Search for correlations with clinical complications
- Evaluate the effect of treatment (including exchange transfusions) on the hemostatic potential.
- Conditions
- Sickle Cell Disease
- Being tested
- Blood sampling - healthy volunteers, Blood sampling - sickle cell patients arm - stable condition, Blood sampling - sickle cell patients arm- exsanguinotransfusion needed, Blood sampling - sickle cell patients arm - vaso-occlusive crisis.
- Keywords
- Hemostatic potential, Sickle cell disease, Thrombin generation 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 sampling - healthy volunteersOther
Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once.
Blood sampling - sickle cell patients arm - stable conditionOther
Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once.
Blood sampling - sickle cell patients arm- exsanguinotransfusion neededOther
Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once, before and after the exsanguinotransfusion.
Blood sampling - sickle cell patients arm - vaso-occlusive crisis.Other
Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once.
| Study group | Role | What they receive |
|---|---|---|
| Sickle cell disease | Experimental | This arm will include an approximate number of 50 sickle cell disease patients, homozygous and heterozygous. Receives: Other: Blood sampling - sickle cell patients arm - stable condition; Other: Blood sampling - sickle cell patients arm- exsanguinotransfusion needed; Other: Blood sampling - sickle cell patients arm - vaso-occlusive crisis. |
| Control | Other | This arm will include an approximate number of 30 healthy volunteers. Receives: Other: Blood sampling - healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulation markers
The following coagulation markers will be assessed in the blood samples: thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
Coagulation markers
The following coagulation markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
Coagulation markers
The following coagulation markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
Coagulation markers
The following coagulation markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
Coagulation markers
The following markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each volunteer.
Measured: healthy volunteers: after informed consent signature, within maximum two years time
Hemolysis markers
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
Hemolysis markers
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
Hemolysis markers
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
Hemolysis markers
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
Hemolysis markers
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each volunteer.
Measured: healthy volunteers: after informed consent signature, within maximum two years time
Microparticles level
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS.This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
Microparticles level
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS. This will be measured only once for each patient, for this health status.
Measured: sickle cell patients -if exsanguinotransfusion - immediately prior exsanguinotransfusion, within maximum two years time
Microparticles level
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS.This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
Microparticles level
Will be measured both by a capture method (Zymuphen) and FACS.This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
Microparticles level
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS. This will be measured only once for each patient, for this health status.
Measured: healthy volunteers: after informed consent signature, within maximum two years time
Inflammatory markers
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
Inflammatory markers
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
Inflammatory markers
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
Inflammatory markers
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Measured: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
Inflammatory markers
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each volunteer.
Measured: healthy volunteers - after informed consent signature, within maximum two years time
Vascular markers
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each patient, for this health status
Measured: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
Vascular markers
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each patient, for this health status
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
Vascular markers
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each patient, for this health status
Measured: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
Vascular markers
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each volunteer.
Measured: healthy volunteers - after informed consent signature, within maximum two years time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anne Demulder, Brugmann University Hospital
- Investigators
- Anne Demulder, MD, Principal investigator, CHU BrugmannBhavna Mahadeb, Principal investigator, St Pierre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565082
- Sponsor's protocol ID
- CHUB-Drepanocytose-Hemostatic
- Status last verified
- Jul 2016
- First submitted
- 18 Sep 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Le PQ, Ferster A, Cotton F, Vertongen F, Vermylen C, Vanderfaeillie A, Dedeken L, Heijmans C, Ketelslegers O, Dresse MF, Gulbis B. Sickle cell disease from Africa to Belgium, from neonatal screening to clinical management. Med Trop (Mars). 2010 Dec;70(5-6):467-70.
PubMed 21516988Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.
PubMed 21131035Ataga KI, Key NS. Hypercoagulability in sickle cell disease: new approaches to an old problem. Hematology Am Soc Hematol Educ Program. 2007:91-6. doi: 10.1182/asheducation-2007.1.91.
PubMed 18024615De Franceschi L, Cappellini MD, Olivieri O. Thrombosis and sickle cell disease. Semin Thromb Hemost. 2011 Apr;37(3):226-36. doi: 10.1055/s-0031-1273087. Epub 2011 Mar 31.
PubMed 21455857Manci EA, Culberson DE, Yang YM, Gardner TM, Powell R, Haynes J Jr, Shah AK, Mankad VN; Investigators of the Cooperative Study of Sickle Cell Disease. Causes of death in sickle cell disease: an autopsy study. Br J Haematol. 2003 Oct;123(2):359-65. doi: 10.1046/j.1365-2141.2003.04594.x.
PubMed 14531921Hemker HC, Giesen P, Al Dieri R, Regnault V, de Smedt E, Wagenvoord R, Lecompte T, Beguin S. Calibrated automated thrombin generation measurement in clotting plasma. Pathophysiol Haemost Thromb. 2003;33(1):4-15. doi: 10.1159/000071636.
PubMed 12853707Noubouossie DF, Le PQ, Corazza F, Debaugnies F, Rozen L, Ferster A, Demulder A. Thrombin generation reveals high procoagulant potential in the plasma of sickle cell disease children. Am J Hematol. 2012 Feb;87(2):145-9. doi: 10.1002/ajh.22206. Epub 2011 Nov 4.
PubMed 22052675Noubouossie DC, Le PQ, Rozen L, Debaugnies F, Ferster A, Demulder A. Evaluation of the procoagulant activity of endogenous phospholipids in the platelet-free plasma of children with sickle cell disease using functional assays. Thromb Res. 2012 Aug;130(2):259-64. doi: 10.1016/j.thromres.2011.10.016. Epub 2011 Nov 12.
PubMed 22079446
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients
- ClinicalTrials.gov ID
- NCT02565082
- Acronym / sponsor ID
- CHUB-Drepanocytose-Hemostatic
- Conditions
- Sickle Cell Disease
- Keywords
- Hemostatic potential, Sickle cell disease, Thrombin generation test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Oct 2015 (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.
Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid sequence of the β chain of hemoglobin.
The most expressive and most frequent complication of the disease is vaso-occlusive crisis, dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic biological disturbances are observed in sickle cell patients.Sickle cell disease is considered nowadays as a hypercoagulable state.
However, the approach used so far to the measure of clotting in sickle cell disease was segmented in the sense that the various components of the hemostatic balance were studied separately.The thrombin generation test is a functional test which explores the coagulation globally, integrating both pro players that anticoagulants actors in the system. The investigators already used this test to demonstrate that the hemostatic potential was high in a cohort of affected children compared to control children of the same age.
This test will be used to characterize the hemostatic potential of adult sickle cell patients followed at the CHU Brugmann Hospital.
Detailed description
Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid sequence of the β chain of hemoglobin. This is the most common genetic disease in the world. The majority of patients are in Sub-Saharan Africa; however, the increase in migratory movements of populations helps to move patients out of the initial zones of the disease.
According to recent data, about 400 patients would be followed in the Belgian hospitals, and about 1 in 1500 newborns in Belgium would be a major carrier of hemoglobinopathies. The most expressive and most frequent complication of the disease is vaso-occlusive crisis, dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic biological disturbances are observed in sickle cell patients. Their contribution to the course of the disease is becoming increasingly stressing. Among them are intravascular hemolysis, hyper-adhesion of blood cells to vascular endothelium, inflammation, oxidative stress, vasculopathy and bleeding disorders.
Sickle cell disease is considered nowadays as a hypercoagulable state. Indeed, sickle cell patients have a high risk of non-hemorrhagic stroke, thrombosis in the pulmonary arteries and deep vein thrombosis that are otherwise associated with mortality and high morbidity. Many anomalies at various levels in the hemostatic system demonstrate coagulation activation even in clinically stable condition.
However, the approach used so far to the measure of clotting in sickle cell disease was segmented in the sense that the various components of the hemostatic balance were studied separately. This scale is complex, this approach difficult to give a comprehensive and integrated picture of the various disturbances in the system. The thrombin generation test is a functional test which explores the coagulation globally, integrating both pro players that anticoagulants actors in the system. The investigators have used this test to demonstrate that the hemostatic potential was high in a cohort of affected children compared to control children of the same age. In this cohort high hemostatic potential was related to the rate of circulating microparticles and intravascular hemolysis rate. Studies are underway to look for correlations between the hemostatic potential and clinical complications in this pediatric cohort.
The use of thrombin generation test for the study of hemostasis in adult patients with sickle cell disease, and the contribution of coagulation disorders with the occurrence of complications of the disease remain little known. The investigators will therefore:
- Characterize the hemostatic potential of adult sickle cell patients followed at the CHU Brugmann
- Search for links between the hemostatic potential and other biological phenomena observed during the disease (intravascular hemolysis, microparticles, vasculopathy, inflammation)
- Search for correlations with clinical complications
- Evaluate the effect of treatment (including exchange transfusions) on the hemostatic potential.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sickle cell disease | Experimental | Other: Blood sampling - sickle cell patients arm - stable condition, Other: Blood sampling - sickle cell patients arm- exsanguinotransfusion needed, Other: Blood sampling - sickle cell patients arm - vaso-occlusive crisis.This arm will include an approximate number of 50 sickle cell disease patients, homozygous and heterozygous. |
| Control | Other | Other: Blood sampling - healthy volunteersThis arm will include an approximate number of 30 healthy volunteers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sickle cell disease group: Sickle cell disease patients aged over 18 years
- Healthy volunteers group: Healthy volunteers, age matching with the sickle cell disease group
Key exclusion criteria (2 listed)
- Sickle cell disease group: Pregnant women, dialysis patients, patients with an hepatic impairment, patients under treatments that can interfere with coagulation
- Healthy volunteers group: Pregnant women, known chronical disease, acute inflammatory syndrome, hemostasis disorder, abnormal complete blood count
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 sampling - healthy volunteersFour citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once. | Other | Control |
| Blood sampling - sickle cell patients arm - stable conditionFour citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once. | Other | Sickle cell disease |
| Blood sampling - sickle cell patients arm- exsanguinotransfusion neededFour citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once, before and after the exsanguinotransfusion. | Other | Sickle cell disease |
| Blood sampling - sickle cell patients arm - vaso-occlusive crisis.Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once. | Other | Sickle cell disease |
Primary outcome
Coagulation markers
Time frame: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
The following coagulation markers will be assessed in the blood samples: thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Coagulation markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
The following coagulation markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Coagulation markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
The following coagulation markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Coagulation markers
Time frame: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
The following coagulation markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each patient, for this health status.
Coagulation markers
Time frame: healthy volunteers: after informed consent signature, within maximum two years time
The following markers will be assessed in the blood samples:thrombin and thrombomodulin, protein C, protein S, antithrombin, D-dimer, factor VIII, TFPI (physiological inhibitor of the extrinsic pathway of coagulation). This will be measured only once for each volunteer.
Hemolysis markers
Time frame: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Hemolysis markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Hemolysis markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Hemolysis markers
Time frame: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each patient, for this health status.
Hemolysis markers
Time frame: healthy volunteers: after informed consent signature, within maximum two years time
Will be measured in the blood samples by the following markers:plasmatic hemoglobin level and the lactate dehydrogenase level.This will be measured only once for each volunteer.
Microparticles level
Time frame: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS.This will be measured only once for each patient, for this health status.
Microparticles level
Time frame: sickle cell patients -if exsanguinotransfusion - immediately prior exsanguinotransfusion, within maximum two years time
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS. This will be measured only once for each patient, for this health status.
Microparticles level
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS.This will be measured only once for each patient, for this health status.
Microparticles level
Time frame: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
Will be measured both by a capture method (Zymuphen) and FACS.This will be measured only once for each patient, for this health status.
Microparticles level
Time frame: healthy volunteers: after informed consent signature, within maximum two years time
Will be measured in the blood samples both by a capture method (Zymuphen) and FACS. This will be measured only once for each patient, for this health status.
Inflammatory markers
Time frame: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Inflammatory markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Inflammatory markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Inflammatory markers
Time frame: sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each patient, for this health status.
Inflammatory markers
Time frame: healthy volunteers - after informed consent signature, within maximum two years time
The following markers will be assessed in the blood samples: inflammatory cytokines, TNF, usCRP and interleukines. This will be measured only once for each volunteer.
Vascular markers
Time frame: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each patient, for this health status
Vascular markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each patient, for this health status
Vascular markers
Time frame: sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each patient, for this health status
Vascular markers
Time frame: healthy volunteers - after informed consent signature, within maximum two years time
The following markers will be assessed in the blood samples: soluble thrombomodulin, von Willebrand factor, vascular endothelial growth factor, protein C endothelial factor. This will be measured only once for each volunteer.
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 26 Jul 2016.
- Background: PubMed 21516988Le PQ, Ferster A, Cotton F, Vertongen F, Vermylen C, Vanderfaeillie A, Dedeken L, Heijmans C, Ketelslegers O, Dresse MF, Gulbis B. Sickle cell disease from Africa to Belgium, from neonatal screening to clinical management. Med Trop (Mars). 2010 Dec;70(5-6):467-70.
- Background: PubMed 21131035Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.
- Background: PubMed 18024615Ataga KI, Key NS. Hypercoagulability in sickle cell disease: new approaches to an old problem. Hematology Am Soc Hematol Educ Program. 2007:91-6. doi: 10.1182/asheducation-2007.1.91.
- Background: PubMed 21455857De Franceschi L, Cappellini MD, Olivieri O. Thrombosis and sickle cell disease. Semin Thromb Hemost. 2011 Apr;37(3):226-36. doi: 10.1055/s-0031-1273087. Epub 2011 Mar 31.
- Background: PubMed 14531921Manci EA, Culberson DE, Yang YM, Gardner TM, Powell R, Haynes J Jr, Shah AK, Mankad VN; Investigators of the Cooperative Study of Sickle Cell Disease. Causes of death in sickle cell disease: an autopsy study. Br J Haematol. 2003 Oct;123(2):359-65. doi: 10.1046/j.1365-2141.2003.04594.x.
- Background: PubMed 12853707Hemker HC, Giesen P, Al Dieri R, Regnault V, de Smedt E, Wagenvoord R, Lecompte T, Beguin S. Calibrated automated thrombin generation measurement in clotting plasma. Pathophysiol Haemost Thromb. 2003;33(1):4-15. doi: 10.1159/000071636.
- Background: PubMed 22052675Noubouossie DF, Le PQ, Corazza F, Debaugnies F, Rozen L, Ferster A, Demulder A. Thrombin generation reveals high procoagulant potential in the plasma of sickle cell disease children. Am J Hematol. 2012 Feb;87(2):145-9. doi: 10.1002/ajh.22206. Epub 2011 Nov 4.
- Background: PubMed 22079446Noubouossie DC, Le PQ, Rozen L, Debaugnies F, Ferster A, Demulder A. Evaluation of the procoagulant activity of endogenous phospholipids in the platelet-free plasma of children with sickle cell disease using functional assays. Thromb Res. 2012 Aug;130(2):259-64. doi: 10.1016/j.thromres.2011.10.016. Epub 2011 Nov 12.
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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.
Anne Demulder, MD principal investigator
CHU Brugmann
Bhavna Mahadeb principal investigator
St Pierre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling - healthy volunteers, Blood sampling - sickle cell patients arm - stable condition and Blood sampling - sickle cell patients arm- exsanguinotransfusion needed in people with Sickle Cell Disease, run by Brugmann University Hospital at 1 site in Belgium.
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 2 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 26 Jul 2016. 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 Belgium. 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?
Coagulation markers (time frame: sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565082, which also lists 8 linked publications.
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 26 Jul 2016.