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

• Sponsor: BILLOIR (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05376046
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease; Vaso-occlusive Crisis	Biological: Erythrocytic parameters and thrombin generation assay measurement

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease
• Actual Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Sep 1, 2026

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Hospitalisation for Vaso-occlusive crisis within one years [1 year]

   Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Sickle cell disease

Exclusion Criteria:

• <18 years

• pregnancy

• Patient under protective guardianship or curatorship

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen university Hospital	Rouen		France	76000

Sponsors and Collaborators

• BILLOIR

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BILLOIR, Associate Professor, University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT05376046
• Other Study ID Numbers: 2021/0328/OB
• First Posted: May 17, 2022
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by BILLOIR, Associate Professor, University Hospital, Rouen: sickle cell disease; vaso-occlusive crisis; reticulocyte count; thrombin generation assay; hypercoagulability
• Additional relevant MeSH terms: Anemia, Sickle Cell; Thrombophilia; Thrombin

Study Results

No Results Posted as of May 24, 2022