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Not yet recruitingNCT06619093DREPA COAGUpdated Jan 15, 2025

Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation

An observational study in Sickle Cell Disease (SCD), sponsored by Hospices Civils de Lyon. Not yet recruiting at 2 sites in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
200
Ages
8 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Sickle Cell Disease (SCD)

Keywords

  • Hemolysis
  • Coagulation
  • Red blood cell
  • Sickle cell disease
03

In context

Anemia, Sickle Cell

1,125 studies on the registry are indexed under Anemia, Sickle Cell; 239 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 295 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,854 studies on the registry; 441 are open to participants now.

Browse Hospices Civils de Lyon studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • High hemolytic group

    Lactate Dehydrogenase Level \> 484 IU/L

    Other: blood sampling

  • Low hemolytic group

    Lactacte Dehydrogenase Level less or equal to 484 IU/L

    Other: blood sampling

Interventions

  • Otherblood sampling

    3 additional citrate tubes (2.7mL)

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What researchers measure

Primary outcomes

  1. Overall coagulation activity

    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.

    Time frame: Baseline

07

Study locations

2 sites
  • Insitut Hématologique et Oncologique Pédiatrique (IHOPe)
    Lyon, 69008, France
  • Service de Médecine Interne - Hôpital Edouard Herriot
    Lyon, 69008, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Feb 2028, 36 months later.

Of 126 non-industry observational studies under Anemia, Sickle Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 109. This study's planned 36 months is below that.

Counting every sponsor, half of 136 studies reached it within 49 months; a quarter within 24 and three quarters within 109.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2024
First posted
Oct 1, 2024
StartEst.
Feb 1, 2025
Primary completionEst.
Feb 1, 2028
CompletionEst.
Feb 1, 2028
Last update
Jan 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06619093
Lead sponsor
Hospices Civils de Lyon
Collaborators
Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Feb 1, 2025 (estimated)
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Jan 15, 2025

Study contacts

Corine Halfon-Domenech, Dr
Contact
Carine.HALFONDOMENECH@ihope.fr
0033469166550 ext. +33
Philippe CONNES, Pr
Contact
philippe.connes@univ-lyon1.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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