Status:
NOT_YET_RECRUITING
Early-goal Directed Automated Red Blood Cell Exchange for Acute Chest Syndrome in Sickle Cell Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Chest Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive pain crisis (VOC), which may evolve to acute chest syndrome (ACS), the most common cause of death among adult patients with SCD. ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patient with major sickle cell disease syndrome (SS, SC, Sβ0 or Sβ+)
- ACS, as defined by the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging
- Requiring supplemental oxygen ≥ 2 L/min for SpO2 ≥ 95%
- With an indication for REX given the hypoxemic ACS, as per recommendations
- Express informed consent from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy relatives to give consent NB: Patients not affiliated to social security will be included in the study given the precarious social situation of many patients with SCD
Exclusion
- Patient having both ACS criteria and need for supplemental oxygen ≥ 2 L/min for SpO2 ≥ 95% since more than 72 hours
- Red blood cell transfusion or REX during the current ACS episode
- Any past medical history of delayed haemolytic transfusion reaction
- History of \< 12 transfused RBC or anti-red blood cell antibody production on the one hand and no possibility for matching on Rh/K, antibody specificity, and extended to Duffy (Fya), Kidd (Jka and Jkb) and MNS (M, N, S and s) phenotypes on the other hand (12)
- Known legal incapacity (guardianship, curatorship)
- Prisoners or subjects who are involuntarily incarcerated
- Anatomical factors precluding placement of an adequate venous access
- Known pregnancy or current lactation
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06214845
Start Date
March 1 2024
End Date
September 1 2026
Last Update
January 22 2024
Active Locations (1)
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1
Armand MEKONTSO DESSAP
Créteil, Val De Marne, France, 94010