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.: PACTR201712002839259 Date of Approval: 05/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Perioperative heparinase rotational thromboelastometry monitoring in adult living related liver transplantation.
Official scientific title Perioperative heparinase rotational thromboelastometry monitoring in adult living related liver transplantation.
Brief summary describing the background and objectives of the trial Release of heparin or heparin-like substances has been noted after reperfusion of the donor liver. This work is designed to study the incidence of a heparin-like effect in recipients of living donor liver transplantation during the various stages. of the transplant procedure and through their early postoperative course using both the standard coagulation laboratory tests (SCT) and the point of care viscoelastic test rotational thromboelastomety (ROTEM) particularly the Heparinase ROTEM (HEPTEM). The aim of this work is to study the relationship between the ROTEM parameters and other related SCTs and if a significant correlation exists and to investigate the routine use postoperative heparin infusion in an attempt to reduce thromboembolic complications and if it is of clinical and laboratory effect.
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 Diagnosis / Prognosis
Anticipated trial start date 01/09/2015
Actual trial start date 01/09/2015
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date 31/08/2017
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 38
Recruitment status Completed
Publication URL https://www.morressier.com/article/04--perioperative-heparinase-rotational-thromboelastometry-monitoring-during-adult-living-related-liver-transplantation/5aeb0acc07b0d6001a79ab48
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 randomizaton. Block size 4 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hypercoagulable Fentanyl 2 µg/kg, Propofol, 2 mg/kg, and Rocrounimn 0.6-0.9 mg/kg (1) preoperative, (2) dissection phase, (3) during anhepatic phase, (4) after reperfusion, (5) first postoperative day, (6) third postoperative day, (7) seventh postoperative day. Rotation Thromboelastometry (ROTEM, Tem International GmbH, Munich,Germany). It provides four independent measuring channels and assays with different activators, and additives. The method measures the viscoelastic properties of the clot and provides information on the speed of coagulation initiation, kinetics of clot growth, clot strength and breakdown. Coagulation samples will be taken. 38
Control Group Non Hypercoagulable Fentanyl 2 µg/kg, Propofol, 2 mg/kg, and Rocrounimn 0.6-0.9 mg/kg (1) preoperative, (2) dissection phase, (3) during anhepatic phase, (4) after reperfusion, (5) first postoperative day, (6) third postoperative day, (7) seventh postoperative day. 38 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients with end stage liver disease scheduled for live adult liver transplantation were enrolled within a 2 year study period. Any factor that interfere with coagulation such as patient on oral anticoagulant, or on procoagulant as activated factor seven (Novoseven). 30 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 05/09/2015 National Liver Institute IRB
Ethics Committee Address
Street address City Postal code Country
Hussin Abd Alghafaar st. branch of Gamal Abd Elnaser st.behind teaching hospital Shbin Elkom 32512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clotting Time (CT) of heparinase ROTAM Preoperative,intraoperative at the dissection phase, 10 minutes into the anhepatic phase, 5 minutes after the reperfusion phase, postoperatively on day 1, 3 and 7
Primary Outcome Maximal Clot Firmness (MCF) of heparinase ROTAM Preoperative, intraoperative at the dissection phase, 10 minutes into the anhepatic phase, 5 minutes after the reperfusion phase, postoperatively on day 1, 3 and 7
Secondary Outcome Post-operative heparin infusion effect on ROTAM and standard coagulation tests Postoperatively on day 1, 3 and 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hepatology and Tropical Medicine Research Institute 10 Kasr Alaini street Cairo 12613 Egypt
National Liver Institute Hussin Abd Alghafaar st. branch of Gamal Abd Elnaser st.behind teaching hospital Shbin Elkom 32512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty Medicine, of Menoufia University Hussin Abd Alghafaar st. branch of Gamal Abd Elnaser st.behind teaching hospital Shbin Elkom 32512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty Medicine, of Menoufia University Hussin Abd Alghafaar st. branch of Gamal Abd Elnaser st.behind teaching hospital Shbin Elkom 32512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdel-Raouf Metwally Alsafarat district block 5, building 8, appartment 3 Nasr city_Cairo 11765 Egypt
Khaled Ahmed Yassen Hussin Abd Alghafaar st. branch of Gamal Abd Elnaser st.behind teaching hospital Shbin Elkom 32512 Egypt
Safaa Mohamed Helal Faculty of Medicine, Menoufia University. Hussin Abd Alghafaar st Shbin Elkom 32512 Egypt
Emad Kamel Refaat National Liver Institute Hussin Abd Alghafaar st. Shbin Elkom 32512 Egypt
Sherin Dawoud Youssef 10KasrAlaini street Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassen kyassen61@hotmail.com 00201063080170 Hussin Abd Alghafaar st
City Postal code Country Position/Affiliation
Shbeen Elkoom 32512 Egypt Professor of Anaesthesia and Intensive Care
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 Ahmed Metwally drahmedabdelraouf@yahoo.com 002-01100085450 Hussin Abd Alghafaar st
City Postal code Country Position/Affiliation
Shbeen Elkoom 32512 Egypt Professor of Anaesthesia and Intensive Care
REPORTING
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