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New Hemolysis Parameters in Sickle Cell Disease (HEMODREP)

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ClinicalTrials.gov Identifier: NCT03040908
Recruitment Status : Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

Tracking Information
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
 (submitted: January 31, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 31, 2017)
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.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 31, 2017)
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:

  • Sickle Cell Disease (HbSS, S beta°, S beta+, SC)
  • Regular follow-up from more than 5 years
  • Written informed consent

Exclusion Criteria:

  • Transplanted patients
  • Hospitalisation for an acute event within 3 months
  • Acute transfusion within 3 months
  • Unable to performed 6-minute walk test
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laurence Dedeken, MD +3224773469 laurence.dedeken@huderf.be
Contact: Bernard Wenderickx +3224773654 bernard.wenderickx@huderf.be
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
Plan to Share IPD: Undecided
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