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Evaluation of Vascular Electrical Stimulation Therapy on Vaso-Occlusive crises in sickle cell patients.

Phase 2
Conditions
Genetic Diseases
Registration Number
PACTR201907740118144
Lead Sponsor
Diavein SAS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Patient aged at least 15 years.
Patients who have signed an informed consent form approved by the Ethics Committee
Patients with SS, SC, Sß0 or Sß + sickle cell anaemia documented by genotype tests
Patients presenting with a vaso-occlusive attack, defined as pain or tenderness evaluated over 6 on a VAS score scale, affecting at least part of the body (including the skull, spine, sternum, ribs, pelvis and/or limbs), progressing for more than 4 hours with analgesics, and that cannot be attributed to another cause.

Exclusion Criteria

Patient with a suspicion of acute chest syndrome, based on the presence of the following symptoms: chest pain and fever, or chest pain and cough, or chest pain and a feeling of shortness of breath.
Patient with severe anaemia characterised by haemoglobin = 5 or showing symptoms of anemia.
Patient for which either symptoms (fever, headache) or diagnostic test results lead to the suspicion of an infection.
Hypothermia patient with T° =35°C
Hyperthermia patient with T° > 38.5°C
Patient wearing a heart pacemaker.
Patient with a known history of heart failure.
Women who are pregnant or breastfeeding.
Any psychological state, family situation, sociological conditions or geographic locations that could hinder compliance with the study procedures or monitoring schedules.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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