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.: PACTR202209744123463 Date of Approval: 12/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of dialyzer geometry and sterilization process on coagulation activation in the extracorporeal circuit in maintenance hemodialysis patients
Official scientific title Effect of dialyzer geometry and sterilization process on coagulation activation in the extracorporeal circuit in maintenance hemodialysis patients
Brief summary describing the background and objectives of the trial Dialyzer membranes with different chemical structures may have different effects on coagulation activation. There is a little data on the effect of the physical structure of dialyzers on coagulation activation in HD. We conducted this study to compare the effect of Helixone FX80 versus Platinum H4 dialyzers on coagulation activation during HD
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 05/09/2022
Actual trial start date 30/09/2022
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 30/09/2022
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
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 Randomised Simple randomization using a randomization 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 hemodialysis two hemodialysis sessions two hemodialysis sessions each patient will receive two HD session by Helixone FX80 and platinum H4 membranes. serum thrombin-antithrombin complex before and after the session and visual inspection of dialyzer staus grades were determined and compared between two dialyzers 20
Control Group measurement of serum thrombinantithrombin complex for cmparison with patients one measurement measurement of serum TAT for comparison with patients 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults ≥18 years on thrice weekly MHD for > 3 months good functioning AVF allowing blood flow rate of ≥ 300 ml/min. active infection, use of anticoagulant or antiplatelet therapy, and known allergy to the investigated dialyzer membranes Adult: 19 Year-44 Year 18 Year(s) 75 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 30/08/2022 ain shams faculty of medicine
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome difference of absolute and relative change of serum TAT levels between dialyzers before and after the session
Secondary Outcome comparing visual inspection of dialyzer status between dialyzers after the session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams university hospital HD center 38 Abbassia, Next to the Al-Nour Mosque cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed sary gharib Almagd district, building 466 new obbour 11828 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohamed sary gharib Almagd district, building 466 Qalyubiyya 11828 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed gharib mohamedsary@med.asu.edu.eg +201000322177 Almagd district, building 466
City Postal code Country Position/Affiliation
new obbour 11828 Egypt ain shams university faculty of medicine
Role Name Email Phone Street address
Public Enquiries mohamed gharib mohamedsary@med.asu.edu.eg +201000322177 Almagd district, building 466
City Postal code Country Position/Affiliation
new obbour 11828 Egypt ain shams university faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries mohamed gharib mohamedsary@med.asu.edu.eg +201000322177 Almagd district, building 466
City Postal code Country Position/Affiliation
new obbour 11828 Egypt ain shams university faculty of medicine
Role Name Email Phone Street address
Principal Investigator Khalid Sayed Khalidsamir92@hotmail.com +201146290011 Heliopolis Masr elgadida
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Ain shams university faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes will be provided at the end of the study Statistical Analysis Plan,Study Protocol one year open request access
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