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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR201907740118144
Enrollment
30
Registered
2019-07-29
Start date
2018-06-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Diseases

Interventions

Placebo
VEST NSAID

Sponsors

Diavein SAS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The average time spent in crisis (EVA> 2) by measuring the intensity of pain on an EVA scale in sickle cell patients

Secondary

MeasureTime frame
Evolution of Hb concentration in the blood;Minor and moderate dose of analgesic administered to the patient.

Countries

Cote Divoire

Contacts

Public ContactRenee Paule Botti

Investigator

renepaulebotti@gmail.com+22547334805

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026