Thromboelastography to analyse the clotting ability of blood and its use for analysing function of transplanted kidney renal transplantation surgery

Active, not recruiting

Conditions: patients undergoing renal transplant surgery

Registration Number: CTRI/2018/04/013083

Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences

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 patientâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 30

Inclusion Criteria

patients undergoing living-related renal transplant.

Exclusion Criteria

1.Patientâ€™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).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TEG parameters	At induction, 1 hour after reperfusion and first postoperative day

Secondary Outcome Measures

Name	Time	Method
transfusion requirements and their complications	transfusion requirements and their complications
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

Trial Locations

Locations (1): SGPGIMS
🇮🇳
Lucknow, UTTAR PRADESH, India
SGPGIMS
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Sandeep Sahu
Principal investigator
8004904598
drsandeepsahu09@gmail.com