Early-goal Directed Automated Red Blood Cell Exchange for Acute Chest Syndrome in Sickle Cell Disease

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method to treat a serious complication of sickle cell disease called acute chest syndrome (ACS). ACS occurs when blood vessels in the lungs become blocked, leading to symptoms like fever and difficulty breathing. The trial aims to see if an automated process for exchanging red blood cells can help patients recover faster than the traditional manual method. This automated process not only replaces sickle-shaped blood cells with healthy ones but also removes harmful substances in the blood that can cause further damage.

To participate in the trial, individuals must be at least 18 years old and diagnosed with major sickle cell disease, experiencing ACS that requires supplemental oxygen. Participants will receive either the automated red blood cell exchange treatment or the manual method under careful medical supervision. Importantly, those who cannot provide consent due to their condition can still be included with the consent of their relatives. This study is not yet recruiting participants, but it represents a hopeful step toward improving treatment for those with sickle cell disease experiencing ACS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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