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.: PACTR201712002857722 Date of Approval: 09/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Temporary Portocaval shunt during live donor liver transplantation on the hemodynamics and laboratory parameters
Official scientific title The effects of Temporary Portocaval shunt during live donor liver transplantation on the hemodynamics and laboratory parameters of the anhepatic and reperfusion phase.
Brief summary describing the background and objectives of the trial Temporary portocaval shunt (TPCS) is a surgical option to help reduce gut venous congestion during the dissection phase helps minimize reperfusion injury and blood loss in difficult cases, but it¿s effects on anesthetic intraoperative management needs to be investigated. Aim is to evaluate the effects of TPCS on systemic haemodynamics and laboratory parameters during the anhepatic and reperfusion phases
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,End-stage liver disease for scheduled liver transplantation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2014
Actual trial start date 01/02/2014
Anticipated date of last follow up 30/11/2017
Actual Last follow-up date 30/11/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TPCS Surgical shunt applied 30
Control Group Control No shunt done 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hepatocellular carcinoma end stage liver diseases expected small for size syndrome non-cirrhotic causes of transplantation extensive portal vain thrombosis well formed Porto-systemic shunt 18 Year(s) 65 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 15/01/2014 IRB: National liver institute
Ethics Committee Address
Street address City Postal code Country
Yassin Abd Alghafaar st Sheben Elkom 32512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Systemic haemodynamics Transeosophegeal Doppler parameters(cardiac output, systemic vascular resistance, corrected flow time) Arterial blood gases(pH, PCO2, HCO3) Blood lactate Dose of hemodynamic support drugs AT end of anhepatic phase 5 minutes post-reperfusion 24 h post operative
Secondary Outcome Blood products transfusion units Operative and postoperative for 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hepatology and Tropical Medicine Research institute kaser elainy street Cairo 11562 Egypt
National liver institute National Liver Institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National liver institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Naglaa mostafa hussien National Liver Institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
Hossam eldien soliman National Liver Institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
Khalied ahmed yassen National Liver Institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
Hossam elsayed elshafiey National Liver Institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
Hanaa saied rashed National Liver Institute Yassin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naglaa Hussin naglaaysh@yahoo.com 002-01142222832 Yassenabdelghafar st
City Postal code Country Position/Affiliation
Shbeen Elkoom 32512 Egypt Lecturer of anesthesia, national liver institute, Menofia university
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Khaled Yassen kyassen61@hotmail.com 00201063080170 Yassenabdelghafar st
City Postal code Country Position/Affiliation
Shbeen Elkoom 32512 Egypt Professor of Anaesthesia and Intnesive Care, Liver Institute, Menofyia University
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