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.: PACTR201803003217132 Date of Approval: 19/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Coagulation and Platelet Function during and after Adult Liver Transplantation with ROTEM
Official scientific title Monitoring of Coagulation and Platelet Function during and after Adult Liver Transplantation with Platelet Rotational thromboelastometry and standard coagulation tests
Brief summary describing the background and objectives of the trial Liver transplantation (LT) is the main treatment for patients with end-stage acute and chronic liver disease not responding to medical treatment. LT is frequently accompanied by considerable bleeding complications and massive transfusion due to severe coagulopathies. The ROTEM platelet system is a new module that could be added to the ROTEM. This work is designed to study the coagulation changes in particular platelets behavior and function in recipients of liver transplantation during and after transplantation and to investigate the relationship of platelets number and function with liver status at the different phases of the procedure, and to study the relationship between the ROTEM parameters and other related Standard Coagulation tests (ST) and if a significant correlation exists particularly correlation between platelets number and MCF of both INTEM and EXTEM and the new ROTEM platelets function parameters . The secondary aim is to determine whether the routine postoperative prophylactic antiplatelet therapy and heparin infusion do have an effect on coagulation by investigating their effects on ROTEM parameters and if an alternation in dosage would be recommended in the future.
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 patients scheduled for liver transplantation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 31/10/2018
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomi sation (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 Rotational Thromboelastometry No dose (Diagnostic tool) Preoperative, intraoperative (anhepatic, post-reperfusion), first, third, seventh, 14th and 21st postoperative day The ROTEM platelet measures platelets aggregation in whole blood samples using impedance aggregometry. The new device is run in conjunction with the ROTEM delta. 20
Control Group Standard platelets count No dose (Diagnostic tool) Preoperative, intraoperative (anhepatic, post-reperfusion), first, third, seventh, 14th and 21st postoperative day Standard platelets count 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
End stage liver disease scheduled for adult liver transplantation. Patients on preoperative oral anticoagulant, antiplatelets. Patients on any drugs affecting platelets function and count or causing pancytopenia e.g Impenam, Diflucan. 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 01/01/2017 IRB: National liver institute
Ethics Committee Address
Street address City Postal code Country
Yassin Abd Alghafaar street Sheben Elkom 32512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Platelet function behaviour Preoperative, intraoperative (anhepatic, post-reperfusion), first, third, seventh, 14th and 21st postoperative day
Secondary Outcome Anti-platelet monitoring First, third, seventh, 14th and 21st postoperative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Yassin Abd Alghafaar street Shbeen Elkoom 32512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National liver insti tute Yassin Abd Alghafaar street 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 street Shbeen Elkoom 32512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ghada Ali Hassan Faculty of Medicine, Yassin Abdel Ghaffar St- from Gamal Abdel Anasar Street Shbeen Elkoom 32511 Egypt
Khaled Ahmed Yassen Gamal Abdelnaser Street Shbeen Elkoom 32512 Egypt
Emad Kamel Refaat Gamal Abdelnaser Street Shbeen Elkoom 32512 Egypt
Wafiya Ramadan Mahdy Faculty of Medicine, Yassin Abdel Ghaffar St- from Gamal Abdel Anasar Street Shbeen Elkoom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassen kyassen61@hotmail.com 00201063080170 Gamal Abdelnaser Street
City Postal code Country Position/Affiliation
Shbeen Elkoom 32512 Egypt Professor of Anaesthesia and Intnesive Care, Liver Institute, Menofy ia 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 Ghada Hassan ghadaali132@yahoo.com 00201001775783 Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St
City Postal code Country Position/Affiliation
Shebin el-kom 32512 Egypt Professor of Anaesthesia, Intensive Care, Pain Management Faculty of Medicine, Menoufyia University
REPORTING
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