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: pactr.samrc.ac.za
Trial no.: PACTR201610001807329 Date of Approval: 04/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Preliminary Assessment of Vascular Electrical Stimulation Therapy for Acute Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Official scientific title Interventional, prospective, randomized, comparative, monocentric study of sickle cell disease patients with Vascular Electrical Stimulation Therapy for treatment of vaso-occlusive crises
Brief summary describing the background and objectives of the trial Vaso-occlusion 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 vaso-occlusion. Vascular Electrical Stimulation Therapy may have promise as a mechanism-of-disease-based therapy for treatment of vaso-occlusion. The objective of the present study is to explore the efficacy and safety of Vascular Electrical Stimulation Therapy (VEST) for the treatment of vaso-occlusive crisis in sickle cell patients 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)
Disease(s) or condition(s) being studied Haematological Disorders,sickle cell disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2016
Actual trial start date 01/11/2016
Anticipated date of last follow up 01/09/2017
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
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)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group VEST Patients 4 hours VEST treatment per day 3 days Patients will receive Vascular Electrical Stimulation Therapy (VEST) treatment for 4 hours placing two electrodes under each calf and two electrodes under each arm at clinical dose (25 to 40V) on the top of conventional fluid and antalgic IV. 10 Placebo
Control Group Control patients 4 hours VEST treament simulation per day 3 days Patients will receive VEST treatment simulation at 0V dose on the top of conventional fluid and antalgic IV. 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with sickle cell anemia (HbSS), hemoglobin SC (HbSC), or HbS-¿-thalassemia (HbS-¿thal) who are experiencing uncomplicated severe acute VOC (score of ¿6 cm on a 10-cm visul analog scale [VAS]) Patients carrying a cardiac pacemaker Pregnancy VOC concomitant with other acute processes including acute chest syndrome and potential serious infection. Regular smoking Transfusion within the last 30 days 15 Year(s) 60 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 27/09/2016 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 Change in pain score using VAS test 24h 48h
Secondary Outcome Pain score using VAS test 2h 4h 6h 8h 10h 12h 18h 36h 60h 72h 84h 96h 108h 120h
Secondary Outcome Narcotic uptake 12h 24h 36h 48h 60h 72h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hopital Saint Camille Secteur 23, Ave Babanguida Ouagadougou 09 BP 444 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 Ouagadougou 12 BP 50 Burkina Faso
W. Henri Gautier Ouedraogo RSS/CNRST Ouagadougou 03 PB7192 Burkina Faso
Dr Eléonore M.P.O 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
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 Etienne L'Hermite elhermite@diavein.com +41 21 791 11 10 Rte de Converney 87
City Postal code Country Position/Affiliation
La Conversion 1093 Switzerland Public relation
Role Name Email Phone Street address
Scientific Enquiries Dr Henri Gautier Ouédraogo whgautier@yahoo.fr 226 70 28 81 22
City Postal code Country Position/Affiliation
ouagadougou 03 BP 7192 Burkina Faso Research fellow at IRSS
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information