Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201907740118144 Date of Approval: 29/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of Vascular Electrical Stimulation Therapy on Vaso-Occlusive crises in sickle cell patients.
Official scientific title 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
Brief summary describing the background and objectives of the trial Vaso-occlusive crises (VOCs) are the most symptomatic manifestations of sickle cell disease. These painful episodes are the most common cause of hospital admissions and cause significant morbidity. Vascular Electrical Stimulation Therapy (VEST) has demonstrated, in various studies, its ability to improve blood circulation through vasodilatation and acceleration of blood circulation as well as its ability to induce increased fibrinolytic activity by significantly increasing (over 200%) the level of tissue plasminogen activator. Considering the low iatrogenic risk and the anti-thrombotic, vasodilatory and blood circulation velocity accelerating properties of VEST, to initiate a monocentric single-blinded controlled clinical study on 30 sickle cell patients with anSS, SC, Sβ0 or Sβ+ phenotype, suffering from vaso-occlusive crises in order to evaluate the potential benefit in reducing the average time spent in crisis
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VESTCI201801
Disease(s) or condition(s) being studied Genetic Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 30/11/2018
Actual Last follow-up date 30/11/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
VEST CI 2018 01 Sponsor
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 0V 4 hours The medical device was plugged to the patient but not stimulation was delivered. Analgesic, hydratation and NSAID is given to all patients. 10 Placebo
Experimental Group VEST 25V 4 hours Stimulation delivered by VEST is applied to to patients, twice a day the first day and once a day the 2nd et 3rd day if pain remains (VAS>2). Analgesic and hydratation is given to all patients. No NSAID is given to this group. 10
Experimental Group VEST NSAID 25V 4h Stimulation delivered by VEST is applied to the patients, twice a day the first day and once a day the 2nd et 3rd day if pain remains (VAS >2). NDAID is taken every 8 hours as long as severe pain remains (VAS>4). Analgesic and saline solution is given to all patients. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient aged at least 15 years. Patients who have signed an informed consent form approved by the Ethics Committee Patients with SS, SC, Sβ0 or Sβ + 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. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/06/2018 COMITE NATIONAL D ETHIQUE DES SCIENCES DE LA VIE ET DE LA SANTE
Ethics Committee Address
Street address City Postal code Country
Institut pasteur BD de l Universite Abidjan 00000 Cote Divoire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The average time spent in crisis (EVA> 2) by measuring the intensity of pain on an EVA scale in sickle cell patients 30m, 1h, 1h30, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 18h, 24h, 36h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 144h
Secondary Outcome Evolution of Hb concentration in the blood 0h, 72h
Secondary Outcome Minor and moderate dose of analgesic administered to the patient. Day1,Day2,Day3,Day4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Service hematologie clinique CHU Yopougon Abidjan Cote Divoire
FUNDING SOURCES
Name of source Street address City Postal code Country
Diavein SAS 227 Rte de la Chapelle St Felix 74540 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Diavein SAS 227 Rte de la Chapelle St Felix 74540 France Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof Gustave Koffi CHU Yopougon Abidjan Cote Divoire
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Etienne LHermite elhermite@diavein.com +33615773953 Rte de Converney 87
City Postal code Country Position/Affiliation
La conversion 1093 Switzerland Chief Executive Officer
Role Name Email Phone Street address
Principal Investigator Gustave Koffi guskof1@yahoo.fr +22507082833 CHU Yopougon
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Professor
Role Name Email Phone Street address
Public Enquiries Renee Paule Botti renepaulebotti@gmail.com +22547334805 CHU Yopougon
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Detailled results will be published within 12 months after trial's completion Clinical Study Report Within 12 months after trial's completion free access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
to be defined in a near futur No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 16/07/2019 It is mandatory Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 16/07/2019 it is mandatory Detailled results will be published within 12 months after trial's completion
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 16/07/2019 it is mandatory Within 12 months after trial's completion
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 16/07/2019 it is mandatory free access
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 16/07/2019 it is mandatory to be defined in a near futur
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 16/07/2019 it is mandatory Clinical Study Report
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 29/07/2019 incorrect trial type CCT RCT