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CTRI Number  CTRI/2018/04/013083 [Registered on: 06/04/2018] Trial Registered Retrospectively
Last Modified On: 27/03/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Thromboelastography to analyse the clotting ability of blood and its use for analysing function of transplanted kidney renal transplantation surgery 
Scientific Title of Study   Thromboelastography to assess the coagulation profile and predict possible transfusion strategy and its utility on graft function in living related renal transplantation surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Sahu 
Designation  Additional Professor 
Affiliation  SGPGIMS 
Address  Department of Anaesthesia, 1st Floor, SGPGIMS,Raebareilly Road, Lucknow-226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904598  
Fax    
Email  drsandeepsahu09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Zakia Saeed 
Designation  Senior Resident 
Affiliation  SGPGIMS 
Address  Department of Anaesthesia, 1st Floor, SGPGIMS,Raebareilly Road, Lucknow-226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  7905116593  
Fax    
Email  zakiasaeed2007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Zakia Saeed 
Designation  Senior Resident 
Affiliation  SGPGIMS 
Address  Department of Anaesthesia, 1st Floor, SGPGIMS,Raebareilly Road, Lucknow-226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  7905116593  
Fax    
Email  zakiasaeed2007@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Postgraduate Institute of Medical Sciences,Rae-Bareli road ,Lucknow ,Uttar Pradesh-226014  
 
Primary Sponsor  
Name  Sanjay Gandhi Postgraduate Institute of Medical Sciences  
Address  Sanjay Gandhi Postgraduate Institute of Medical Sciences,Raebareilly road ,Lucknow ,Uttar Pradesh-226014  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Sahu  SGPGIMS  Department of Anaesthesia, 1st Floor, SGPGIMS,Raebareilly Road, Lucknow-226014
Lucknow
UTTAR PRADESH 
8004904598

drsandeepsahu09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients undergoing renal transplant surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patients undergoing living-related renal transplant.  
 
ExclusionCriteria 
Details  1. Patient’s refusal.
2. Individuals receiving allografts with multiple renal arteries.
3. Cases where laparoscopic donor nephrectomy was converted to open nephrectomy (in lieu of prolonged warm ischaemic time).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TEG parameters  At induction, 1 hour after reperfusion and first postoperative day 
 
Secondary Outcome  
Outcome  TimePoints 
Delayed graft function   Duration of one month post surgery 
graft failure (a return to dialysis dependence), serum creatinine levels, haemorrhagic and thrombotic graft complications, incidences of rejection and venous thrombo-embolism   graft failure (a return to dialysis dependence), serum creatinine levels, haemorrhagic and thrombotic graft complications, incidences of rejection and venous thrombo-embolism  
transfusion requirements and their complications  transfusion requirements and their complications 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/02/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Thromboelastography (TEG) has been proven to be of significant value in the prediction of hyper- and hypocoagulable states for patients undergoing hepatic transplantation and coronary artery bypass graft surgery, however, its role is as-yet undefined in the prediction of clotting related complications of living-related renal transplantation, which may range from severe haemorrhage to thrombosis and failure of the renal allograft. TEG assessment of living related transplant recipients on induction may thus confer significant advantages in the context of diagnosis and management of occult clotting defects. A growing body of evidence suggests that TEG is superior to routine laboratory tests in guiding intra-operative coagulation management.

Aim of this study is to assess the potential applicability of perioperative thromboelastograph (TEG) in the early prediction of delayed graft failure and perioperative complications for living-related renal transplantation.

This single-centered, prospective study after approval by ethics committee of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India and written informed consent from the patients would be conducted over a period of one year in 30 living-related transplant patients. Warm ischaemic time would be kept negligible for the donated organs. Cold ischaemic time would be kept <2 hours. All patients would receive immunosuppression with tacrolimus 0.15 mg/kg/day for 2 days before transplant and mycophenolate 1000 mg bd on the day of transplant or at the start of pretransplant plasmapheresis. At surgery, allograft vascular anastomoses would be to the external/internal iliac vein and artery.

The results of all pre-operative haematology, biochemistry and radiological investigations would be recorded from 24 h prior to surgery upto a period of 7 days postoperatively.

A pre-operative central venous 5-ml blood sample would be drawn prior to the commencement of surgery for the purposes of thromboelastographic analysis and immediately processed by a trained senior perfusionist. A postreperfusion blood sample would be similarly drawn at the point of abdominal closure  and processed for comparison. A postoperative blood sample would be drawn on first postoperative day and processed for comparison.

One-year follow-up data including graft failure, serum creatinine levels, haemorrhagic and thrombotic graft  complications, incidences of rejection and venous thrombo-embolism would be recorded and analysed in the context of TEG data findings. Exclusion criteria would be patient’s refusal, individuals receiving allografts with multiple renal arteries or cases where laparoscopic donor nephrectomy was converted to open nephrectomy.

Statistical analysis would be done by SPSS software version 20.0. Quantitative data would be analysed with student t-test and qualitative data using chi-square and fisher-exact test. Significance would be attributed at P <0.05.

 
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