New Hemolysis Parameters in Sickle Cell Disease (HEMODREP)
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| ClinicalTrials.gov Identifier: NCT03040908 |
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Recruitment Status :
Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : February 12, 2019
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| Tracking Information | |||||||||
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| First Submitted Date | January 24, 2017 | ||||||||
| First Posted Date | February 2, 2017 | ||||||||
| Last Update Posted Date | February 12, 2019 | ||||||||
| Estimated Study Start Date | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Correlation between new biological data and clinical phenotype [ Time Frame: 2 years ] The primary outcome of this study is to validate the relationship between these new biological markers and the clinical phenotype.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
Correlation between new biological data and 6-minute walk test [ Time Frame: 2 years ] The secondary outcome is to confirm the correlation between the 6-minute walk test and the presence of silent infarct and to explore the relationship between these new markers and the 6-minute walk test.
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | New Hemolysis Parameters in Sickle Cell Disease | ||||||||
| Official Title | Evaluation de la capacité Physique Sous Maximale au Moyen du Test de Marche de 6 Minutes Des Enfants et Adultes Jeunes Suivis Pour drépanocytose et Nouveaux paramètres d'hémolyse : Vers Une prédiction Des Complications Vasculaires ? | ||||||||
| Brief Summary | The 6-minute walk (6MWT) test is used in adults and children affected by a wide range of chronic diseases to evaluate their sub-maximal exercise capacity. It reflects the global response of various physiological systems (respiratory, cardio-vascular, neurologic, metabolic and musculosquelettic) in a situation simulating a daily life activity. In children with sickle cell disease, the 6MWT is correlated with a low level of hemoglobin, a low level of fetal hemoglobin and low red cell deformability. Our team previously reported that in a population of children with sickle cell disease, highly treated with hydroxyurea, the sole factor which was independently linked to the 6MWT was the presence of silence infarct. As the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of endothelial and inflammation parameters and new hemolysis markers and b) if the presence of silent infarct and the 6MWT are correlated with this biological markers. This cross-sectional study will include sickle cell disease patients regularly followed for more than 5 years at Hôpital Universitaire des Enfants Reine Fabiola, Centre Hospitalier Universitaire (CHU)-Brugmann, Centre Hospitalier Etterbeek-Ixelles, CHU Saint-Pierre, Cliniques Universitaires Saint-Luc (Bruxelles, Belgium). Inclusion criteria are: sickle cell disease (SS, Sbeta°, SC, Sbeta+), age range : 6 to 25 years, signed informed consent. Exclusion criteria are: transplanted patients, inability to perform the 6MWT (severe cognitive disability, femoral osteonecrosis with functional impairment), hospitalization and/ or transfusion in the last 3 months for acute event. Demographic data and clinical data will be retrospectively recorded. Blood test and 6MWT will be performed in steady state. Studied analysis will be: coagulation factors, free hemoglobin, Pro-B type natriuretic peptide (Pro-BNP), High sensitivity C reactive protein (HS-CRP), Intercellular Adhesion Molecule (ICAM), Vascular Cell Adhesion Molecule (VCAM) and Selectins. With this study, the investigators expect to validate new predictive markers for cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop these complications. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Children and young adults with Sickle Cell Disease | ||||||||
| Condition | Sickle Cell Disease | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
150 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | March 1, 2022 | ||||||||
| Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 6 Years to 25 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03040908 | ||||||||
| Other Study ID Numbers | P2016/ONCO-HEMATO/HEMODREP | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement |
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| Responsible Party | Queen Fabiola Children's University Hospital | ||||||||
| Study Sponsor | Queen Fabiola Children's University Hospital | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Queen Fabiola Children's University Hospital | ||||||||
| Verification Date | February 2019 | ||||||||