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.: PACTR201405000814129 Date of Approval: 21/04/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Coagulation Profile of Recipients with Tendency to Hyper coagulate for Adult Living Liver Transplantation by use of both Routine Lab and Thromboelasto
Official scientific title Study of Coagulation Profile of Recipients with Tendency to Hyper coagulate for Adult Living Liver Transplantation by use of both Routine Lab and Thromboelastometry
Brief summary describing the background and objectives of the trial and objectives of the trial:This work is designed to study the coagulation parameters for recipients of living related liver transplantation with preoperative laboratory markers indicating tendency to hypercoagulability using the standard laboratory tests and rotational thromboelastomety parameters (ROTEM), as well as to investigate the interrelationship between them and to report the incidence of postoperative thrombotic and thromboembolic complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Patients undergoing liver transplantation,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/05/2014
Actual trial start date 01/05/2014
Anticipated date of last follow up 30/11/2014
Actual Last follow-up date 30/11/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Recruiting
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 (block size =4) and the block size was not variable Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Non Hypercoagulable Fentanyl 2 ug/kg, Propofol, 2 mg/kg, and Rocrounimn 0.6-0.9 mg/kg. (1) preoperative, (2) during anhepatic phase, (3) after reperfusion, (4) first postoperative day, (5) third postoperative day, (6) seventh postoperative day. 14 Uncontrolled
Experimental Group Hypercoagulable Fentanyl 2 ug/kg, Propofol, 2 mg/kg, and Rocrounimn 0.6-0.9 mg/kg (1) preoperative, (2) during anhepatic phase, (3) after reperfusion, (4) first postoperative day, (5) third postoperative day, (6) seventh postoperative day. History of the present illness, past history of any associated medical illness, drug history, and family history of hypercoagulability and the investigations will also include prothrombin time (PT) and international normalized ratio (INR), Partial thromboplastin time (PTT) , Thromboelastogram (INTEM, EXTEM, FIBTEM), in add 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Preoperative measurement of the following laboratory tests: protein C, protein S, antithrombin III , factor V leidin Mutation, lupus anticoagulant, homocystein IgG IgM and antiphospholipid Any factor that interfere with coagulation such as patient on heparin, oral anticoagulant, or taking plasma , on procoagulant as activated factor seven (novoseven). 19 Year(s) 63 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 01/04/2014 National Liver Institute IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street SHEBIN el kom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prothrombin time (PT) and international normalized ratio (INR) , Partial thromboplastin time (PTT) , Thromboelastogram (INTEM, EXTEM, FIBTEM),platelet,fibrinogen PREOPERATIVE ,before reperfusion ,after reperfusion, POD 1,3 ,7
Secondary Outcome Preoperative measurement of the following laboratory tests: protein C, protein S, antithrombin III , factor V leidin Mutation, lupus anticoagulant, homocystein IgG IgM and antiphospholipid. PREOPERATIVE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute, Menoufiya University Shebin el kom Al Menoufiya Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin abd elghafar street SHEBIN el kom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute, Menoufiya University Yassin abd elghafar street SHEBIN el kom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Helmy Ibrahim Tanta Elgharbia Egypt
Khaled Ahmed Yassen Yassin abd elghafar street Al Menoufiya Egypt
Abdel Rahman Ahmed Ahmed Tanta Al gharbia Egypt
Ashraf Salah Eldin Hassanin Yassin abd elghafar street Al Menoufiya Egypt
Yasmin abdelsalam Yassin abd elghafar street Al Menoufiya Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassen kyassen61@hotmail.com 002-01063080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Professor of Anesthesia and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient information Manager
Role Name Email Phone Street address
Scientific Enquiries Ashraf Hassanin ashroof2@yahoo.com 002-01001546427 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Lecturer of Anesthesia and Intensive Care
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