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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients undergoing renal transplant surgery, |
|
Intervention / Comparator Agent
|
|
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. |