Prospective, single-centre, clinical trial for evaluation of the efficacy and safety of Vascular Therapy by Electrical Stimulation in the treatment of vaso-occlusive crises in sickle cell patients

Diavein SAS0 个研究点目标入组 30 人开始时间: 2019年7月9日最近更新: 2023年5月29日

试验速览

暂无简介。

•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.

•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.

发起方

Diavein SAS