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.: PACTR202001734652715 Date of Approval: 14/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The South African Registry of acute Aortic Dissections (SARAD)
Official scientific title The South African Registry of acute Aortic Dissections (SARAD)
Brief summary describing the background and objectives of the trial An aortic aortic dissection is a relatively rare condition with potentially catastrophic consequences. There International Registry of Aortic Dissections (IRAD) was established in 1996 to identify victims of this condition, and has added considerably to our understanding of the presentation and management of aortic dissections. IRAD which has published its twenty year results includes 50 centres in 21 countries; but no African centres are included. This study is intended to be a multi-centre , retrospective registry to identify and collect cases of patients who have suffered from acute, thoracic aortic dissections in South Africa. The aim of this study is to understand the difference in clinical presentation, aetiology and management of this condition in South Africa.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SARAD
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Genetic Diseases,Infections and Infestations,Surgery
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/01/2020
Actual trial start date
Anticipated date of last follow up 03/01/2220
Actual Last follow-up date
Anticipated target sample size (number of participants) 10000
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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
Control Group Aortic surgery 1 Day Standard treatment according to treating surgeon 10000 Historical
Experimental Group Aortic surgery 1 Day Aortic graft 100000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Acute aortic dissection Imaging CT scan Echo MRI No imaging available Presentation later than two weeks 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 03/12/2019 South African Medical Association Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Block F, Castle Walk Office Park, Nossob Street, Erasmuskloof, Ext 3, Pretoria 0181 Johannesburg 0181 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality 30 days
Secondary Outcome Organ malperfusion 30 days
Secondary Outcome Cerebrovascular accidents 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life Fourways Hospital Cnr Cedar Rd and Cedar Ave West, Fourways Johannesburg 2055 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Anthony Yip Suite C28, Life Fourways Hospital, Cnr Cedar Rd and Cedar Ave West, Fourways Johannesburg 2055 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anthony Yip Life Fourways Hospital, Cnr Cedar Rd and Cedar Ave West, Fourways Johannesburg 2055 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Catherine Hosking 42 Benmore Road Johannesburg 2196 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anthony Yip dranthonyyip@gmail.com +27118751760 Suite C28, Life Fourways Hospital, Cedar Rd, Fourways
City Postal code Country Position/Affiliation
Johannesburg 2055 South Africa Consultant Cardiologist
Role Name Email Phone Street address
Public Enquiries Anthony Yip dranthonyyip@gmail.co +27118751760 Suite C28, Life Fourways Hospital, Cedar Rd, Fourways
City Postal code Country Position/Affiliation
Johannesburg 2055 South Africa Cardiologist
Role Name Email Phone Street address
Scientific Enquiries Anthony Yip dranthonyyip@gmail.com +27828256340 Suite C28, Life Fourways Hospital, Cedar Rd, Fourways
City Postal code Country Position/Affiliation
Johannesburg 2055 South Africa Cardiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This study is a country wide registry based on retrospective clinical data review. The conditions of ethics approval requires all patient information to be anonymizes and de-identified. Summary data from the registry will be made available was collected, checked, analyzed and audited. Data will only be published once the South African Medical Association has been informed to ensure protection of patients, their privacy and their rights. Study Protocol Within 12 months of data collected and analyzed. Access is only to be granted to fellow health care professionals for scientific knowledge under the strictest conditions of patient anonymity and confidentiality. Publications arising from the data can only be released with permission and after review by the South African Medical Association Ethics committee and of the SARAD working committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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