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.: PACTR201504001083838 Date of Approval: 25/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between retrograde and antegrade peripheral venous cannulation in ICU patients
Official scientific title Comparison between retrograde and antegrade peripheral venous cannulation in ICU patients
Brief summary describing the background and objectives of the trial to assess the incidence of thrombosis around the peripheral venous catheter when inserted either retrograde or antegrade to the direction of blood flow
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied catheter induced peripheral venous thrombosis,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 12/05/2014
Actual trial start date 12/05/2014
Anticipated date of last follow up 15/12/2014
Actual Last follow-up date 15/12/2014
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Randomised computer generated numbers computer generated numbers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group retrograde peripheral venous cannulation once 10 days or thrombus formed retrograde peripheral venous cannulation 40
Control Group ante-grade peripheral venous cannulation once 10 days or thrombus formed ante-grade peripheral venous cannulation 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria will include; - ASA physical status I-IV, - age 18-60 years, - visible cephalic veins in both upper arms, - expected ICU stay of more than ten days, - accessible both arms for cannulation. Exclusion criteria will include; - age less than 18 or more than 60, - coagulopathy (hyper-coagulable or hypo-coagulable states), - inaccessible upper arms for cannulation. - expected duration of ICU stay less than ten days 18 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 25/03/2014 Faculty of Medicine-Beni Suef University
Ethics Committee Address
Street address City Postal code Country
mokbl street Beni Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome start of thrombus formation around the peripheral venous catheter 10 days from insertion with daily ultrasound assessment till removal of catheters.
Secondary Outcome estimation of the indwelling time of the catheter time from start of thrombus formation till extension of thrombus to tip of the catheter or a period of 10 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University hospital Mokbl street Beni Suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine-Beni Suef University Mokbl street Beni Suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine-Beni Suef University Mokbl street Beni Suef 62511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hassan Ismail El-shafei Elmanial street cairo 11562 Egypt
Hany Wafiq Alkady Elmanial street cairo 11562 Egypt
mohamed mohamed abdelhaq Elmanial street cairo 11562 Egypt
mohamed ahmed maher Elmanial street cairo 11562 Egypt
mohamed farid elemady Elmanial street cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelaal Ahmed Mahmoud carnitin7@yahoo.com +201113308866 39 mousa ebn nousir street
City Postal code Country Position/Affiliation
cairo 11471 Egypt lecturer of anesthesiology, faculty of medicine, Beni Suef University
Role Name Email Phone Street address
Public Enquiries Hani Wafiq Alkady hanimwk@yahoo.com +201000966382 elmanial
City Postal code Country Position/Affiliation
cairo 11562 Egypt lecturer of anesthesiology, faculty of medicine, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdelhaq mohamedabdelhaq76@hotmail.com +201000053764 elmanial
City Postal code Country Position/Affiliation
cairo 11562 Egypt lecturer of anesthesiology, faculty of medicine, Cairo University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information