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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201702002009193 Date of Registration: 01/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Preliminary Assessment of Vascular Electrical Stimulation Therapy for Acute VasoOcclusive Crisis in Children With Sickle Cell Disease
Official scientific title Interventional, prospective, randomized, comparative, monocentric study of sickle cell disease children with Vascular Electrical Stimulation Therapy for treatment of vasoocclusive crises
Brief summary describing the background and objectives of the trial Vasoocclusion is central to the painful crises and acute and chronic organ damage in sickle cell disease. Abnormal vascular tone, adhesion, platelet activation and inflammation contributes to the pathophysiology of vasoocclusion. Vascular Electrical Stimulation Therapy may have promise as a mechanism of disease based therapy for treatment of vasoocclusion. The objective of the present study is to explore the efficacy and safety of Vascular Electrical Stimulation Therapy (VEST) for the treatment of vasoocclusive crisis in sickle cell children by evaluating the pain intensity, the overall duration of the crisis and the parenteral narcotic use of the treated patients versus control patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VESTINVOC
Disease(s) or condition(s) being studied Circulatory System,Vasoocclusive crisis of sickle cell disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/04/2017
Actual trial start date
Anticipated date of last follow up 03/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
VEST-BF2017-02
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 randomisation using a randomisation table created by a computer software program. Allocation was determined by the holder of the sequence who is situated off site. Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table created by a computer software program. Allocation was determined by the holder of the sequence who is situated off site. Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table created by a computer software program. Allocation was determined by the holder of the sequence who is situated off site. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with sickle cell anemia (HbSS), or(HbSC) who are experiencing uncomplicated severe acute VOC (score equal or more of 6 cm on a 10cm visul analog scale [VAS]) aged from 5 to 15 years old. Patients carrying a cardiac pacemaker, Pregnancy, VOC concomitant with other acute processes including acute chest syndrome and potential serious infection. Transfusion within the last 30 days 5 Year(s) 15 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 09/09/2016 Comite d'ethique pour la recherche en santé
Ethics Committee Address
Street address City Postal code Country
1200 logements 09 Ouagadougou 09 BP 7009 9 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time spent in severe pain (over 5 in VAS) 1H 2H 3H 4H 5H 6H 8H 10H 12H 18H 24H 30H 36H 48H 60H 72H 84H 96H 108H 120H
Secondary Outcome Narcotic uptake 12h 24h 36h 48h 60h 72h 84h 96h 108h 120h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hopital Charles de Gaulle 979 Boulevard des Tensoba Ouagadougou 01 BP 1198 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof Jacques L'Hermite p/o Modeste RASOLODERA Ouagadougou 01 BF 242 Burkina Faso
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Jacques L'Hermite p/o Modeste RASOLODERA Ouagadougou 01 BF 242 Burkina Faso Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Seni Kouanda IRSS Ouagadougou 03 PB 7192 Burkina Faso
Henri Gautier Ouedraogo IRSS/CNRST Ouagadougou 03 PB 7192 Burkina Faso
Prof Eleonore Kafando Ouagadougou 04 BP 8306 Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seni Kouanda senikouanda@gmail.com 226 70 26 14 62 IRSS
City Postal code Country Position/Affiliation
ouagadougou 03 BP 7192 Burkina Faso Chef de département Biomédical et Santé publique
Role Name Email Phone Street address
Public Enquiries Henri Gautier Ouédraogo gouedraogo@irss.bf 226 70 28 81 22 IRSS
City Postal code Country Position/Affiliation
ouagadougou 03 BP 7192 Burkina Faso Chargé de recherche
Role Name Email Phone Street address
Scientific Enquiries Etienne L Hermite elhermite@bioxtal.com +41 21 791 11 10 Rte de Converney 87
City Postal code Country Position/Affiliation
La Conversion 1093 Switzerland CEO
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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