Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease (SCD-TGA) (SCD-TGA)

May 17, 2022 updated by: BILLOIR

Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease

Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation.

The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • Recruiting
        • Rouen University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients in the study were diagnosed and treated for SCD at Rouen University Hospital. Patients were included during annual visit in our tertiary centre. Patients with VOC were included less than 24hours after admission to emergency department. All patients treated with hydroxyurea have been treated for at least three years. All patients received a systematic annual visit to determine VOC development in the year. Patients were analyzed in four subgroups based on genotype and clinical status:

  • homozygous SCD (S/S) or β0 thalassemia (S/β0) at steady state;
  • homozygous SCD with α3.7 thalassemia (S/Sα3.7) at steady state;
  • heterozygous SCD with C haemoglobin (S/C) or β+ thalassemia (S/β+)at steady state;
  • patients hospitalized for VOC with any genotype.

Description

Inclusion Criteria:

  • Sickle cell disease

Exclusion Criteria:

  • <18 years
  • pregnancy
  • Patient under protective guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sickle cell disease

Confirmed sickle cell disease withHaemoglobin profile was determined by high performance liquid chromatography (HPLC) (Variant II Biorad, California, United States), by capillary electrophoresis on Capillarys 3 Octa® (Kit hydragel hémoglobine Sebia, Lisses, France) and iso-electrofocalisation.

Patients were included during injury evaluation in our tertiary centre.
Biological: Erythrocytic parameters and thrombin generation assay measurement
Erythrocytic parameters and thrombin generation assay measurement
Healthy
25 healthy controls matched on age and gender
Biological: Erythrocytic parameters and thrombin generation assay measurement
Erythrocytic parameters and thrombin generation assay measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalisation for Vaso-occlusive crisis within one years
Time Frame: 1 year
Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BILLOIR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

April 29, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0328/OB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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