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.: PACTR201712002847839 Date of Approval: 07/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Rotational thromboelastometry versus standard coagulation tests for adult liver transplant recipients with thrombophilia
Official scientific title Rotational thromboelastometry versus standard coagulation tests for adult liver transplant recipients with thrombophilia
Brief summary describing the background and objectives of the trial Liver cells are the primary source for most of the coagulation factors production, which when affected by chronic illness or hepatic dysfunction, is reflected frequently into prolongation and delay in the coagulation process particularly in patients with end stage liver disease. Prolonged prothrombin time (PT) and activated partial thromboplastin time (aPTT) is observed frequently in liver transplant candidates. Hypercoagulation can lead to serious vascular thromboembolic complications within the liver transplanted graft vessels, which if extensive can lead to a life-threatening situation. Standard coagulation tests (SCT) have a limited ability to diagnose hypercoagulation. Recognized risk factors for thrombosis are generally related to one or more elements of Virchow's triad (stasis, vessel injury and hypercoagulability). Major surgery itself can induce a hypercoagulable state during the postoperative period, and this hypercoagulability has been implicated in the pathogenesis of postoperative thrombotic complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Liver cirrhosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/11/2016
Actual trial start date 01/11/2016
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 31/12/2017
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 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 ROTEM Preoperative, and throughout phase of operation Measurement using INTEM, EXTEM, FIBTEM 20
Control Group Laboratory Preoperative, and throughout phase of operation Measurement using INTEM, EXTEM, FIBTEM 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients with end stage liver disease scheduled for live donor liver transplantation - Active overt infection - Patients undergoing re-transplantation. - Recipients receiving grafts with multiple vessel anomilies (trifurcated portal vein, double hepatic artery) 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 17/08/2017 IRB: The ethics committee of the faculty of medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17Chamblion street, el azareeta Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measure the perioperative coagulation changes Preoperative and during all phase of operation
Primary Outcome Outcome 28-days survival Rejection Complications during 28 postoperative days.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine, University of Alexandria 17Chamblion street, el azareeta Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, University of Alexandria 17Chamblion street, el azareeta Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthesiology, Faculty of Medicine, University of Alexandria 17Chamblion street, el azareeta Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mervat Moustafa Abd-Elmaksoud 17Chamblion street, el azareeta Alexandria 21521 Egypt
Khaled Ahmed Yassen National Liver Institute Hussin Abd Alghafaar st Shbeen Elkoom 32512 Egypt
Ahmed Mohamed El-gendi 17Chamblion street, el azareeta Alexandria 21521 Egypt
Rehab Abd-Elraouf Abd El-Aziz 17Chamblion street, el azareeta Alexandria 21521 Egypt
Hisham Mohamed Gamal Eldine Hassan 17Chamblion street, el azareeta Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mervat Abd-Elmaksoud Mervat_abdelmaksoud@hotmail.com 002-01007018359 Military building street 6 home 10 Mustafa Kamel
City Postal code Country Position/Affiliation
Alexandria 21529 Egypt Professor of Anaesthesia, Faculty of Medicine, University of Alexandria
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 Hussin Abd Alghafaar st
City Postal code Country Position/Affiliation
Shbeen Elkoom 32512 Egypt Professor of Anaesthesia and Intnesive Care, Liver Institute, Menofyia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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