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New treatment option for Sickle Cell Disease
Official title High-flow Oxygen for Vaso-occlusive Pain Crisis
ClinicalTrials.gov ID: NCT03976180
What this study is testing
- What it's testing
- 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. Currently, there is no safe and effective treatment to abort VOC or prevent secondary ACS.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- Patient with major sickle cell disease syndrome (SS, SC, Sβ0 or Sβ+);
- VOC as defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or...
- Intermediate-to-high risk for secondary ACS derived from the PRESEV score (Bartolucci et al, EBioMedicine 2016) as follows: a reticulocyte count...
- Informed consent;
You likely can't join if
- The presence at inclusion of a primary ACS. Primary ACS is defined by the combination at time of randomization of a clinical sign [chest pain or...
- VOC with need of parenteral opioids lasting longer than 72 hours at time of inclusion;
- Known pregnancy or current lactation; Women of child bearing potential will be tested for pregnancy before inclusion;
- Known cerebral vasculopathy or past medical history of stroke, due to Moya Moya or persisting visible macrovessel stenosis/occlusion;
- Known ischemic heart disease or typical chest angina;
- Patient who is currently enrolled in other investigational drug study;
See the full eligibility criteria
- Age ≥ 18 years;
- Patient with major sickle cell disease syndrome (SS, SC, Sβ0 or Sβ+);
- VOC as defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, that requires opioids and is not attributable to other causes;
- Intermediate-to-high risk for secondary ACS derived from the PRESEV score (Bartolucci et al, EBioMedicine 2016) as follows: a reticulocyte count \>216 G/L OR at least two of the followings : i) spine and/or pelvis CPS...
- Informed consent;
- Patient affiliated to social security
- The presence at inclusion of a primary ACS. Primary ACS is defined by the combination at time of randomization of a clinical sign [chest pain or auscultatory abnormality (crepitants and/or bronchial breathing)] with a...
- VOC with need of parenteral opioids lasting longer than 72 hours at time of inclusion;
- Known pregnancy or current lactation; Women of child bearing potential will be tested for pregnancy before inclusion;
- Known cerebral vasculopathy or past medical history of stroke, due to Moya Moya or persisting visible macrovessel stenosis/occlusion;
- Known ischemic heart disease or typical chest angina;
- Patient who is currently enrolled in other investigational drug study;
- Known legal incapacity,
- Prisoners or people who are involuntarily incarcerated
- Anatomical factors precluding placement of a nasal cannula
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.