Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation (DREPA COAG)

January 14, 2025 updated by: Hospices Civils de Lyon
Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level > 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69008
        • Insitut Hématologique et Oncologique Pédiatrique (IHOPe)
        • Contact:
      • Lyon, France, 69008

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with sickle cell disease, followed regularly by the Sickle Cell Center of Lyon Hospitals (Hospices Civils de Lyon).

Description

Inclusion Criteria:

  • Aged 8 years or older
  • Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C
  • Patient covered by a social security or equivalent health insurance plan
  • Collection of the non-opposition for adults
  • Information of the minor and collection of the non-opposition from both parents

Exclusion Criteria:

  • Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion
  • Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator's discretion)
  • Patient under guardianship, curatorship, or legal protection
  • Patient subject to a legal protection measure
  • Person admitted to a health or social care institution for purposes other than research

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High hemolytic group
Lactate Dehydrogenase Level > 484 IU/L
Other: blood sampling
3 additional citrate tubes (2.7mL)
Low hemolytic group
Lactacte Dehydrogenase Level less or equal to 484 IU/L
Other: blood sampling
3 additional citrate tubes (2.7mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall coagulation activity
Time Frame: Baseline
To compare the overall coagulation activity (measurement of in vitro clot formation by rotary thromboelastometry (ROTEM)) between sickle cell patients with a severe haemolytic phenotype and those with a less severe haemolytic phenotype.
Baseline

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Collaborators

Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424

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 (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0679

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

product manufactured in and exported from the U.S.

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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