Sickle Cell Disease Clinical Trial
Official title:
Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann Hospital | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital |
Belgium,
Ataga KI, Key NS. Hypercoagulability in sickle cell disease: new approaches to an old problem. Hematology Am Soc Hematol Educ Program. 2007:91-6. Review. — View Citation
De 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. Review. — View Citation
Hemker HC, Giesen P, Al Dieri R, Regnault V, de Smedt E, Wagenvoord R, Lecompte T, Béguin S. Calibrated automated thrombin generation measurement in clotting plasma. Pathophysiol Haemost Thromb. 2003;33(1):4-15. — View Citation
Lê 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. — View Citation
Manci 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. — View Citation
Noubouossie DC, Lê 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. — View Citation
Noubouossie DF, Lê 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. — View Citation
Rees 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time | No |
Primary | 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. | sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time | No |
Primary | 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. | healthy volunteers: after informed consent signature, within maximum two years time | No |
Primary | 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. | sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time | No |
Primary | 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. | sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time | No |
Primary | 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. | healthy volunteers: after informed consent signature, within maximum two years time | No |
Primary | 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. | sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time | No |
Primary | 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. | sickle cell patients -if exsanguinotransfusion - immediately prior exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time | No |
Primary | 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. | healthy volunteers: after informed consent signature, within maximum two years time | No |
Primary | 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. | sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time | No |
Primary | 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. | sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | sickle cell patients - if vaso-occlusive crisis - during the vaso-occlusive crisis, within maximum two years time | No |
Primary | 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. | healthy volunteers - after informed consent signature, within maximum two years time | No |
Primary | 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 | sickle cell patients - stable condition - at upcoming hospital routine follow-up, within maximum two years time | No |
Primary | 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 | sickle cell patients - if exsanguinotransfusion needed - immediately prior exsanguinotransfusion, within maximum two years time | No |
Primary | 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 | sickle cell patients - if exsanguinotransfusion needed - immediately after exsanguinotransfusion, within maximum two years time | No |
Primary | 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. | healthy volunteers - after informed consent signature, within maximum two years time | No |
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