Changes in Haemostatic Parameters During Renal Transplantation; V 3.0
Research type
Research Study
Full title
Changes in Haemostatic Parameters and Use of Routine Thromboprophylaxis in Recipients and Donors Undergoing Renal Transplantation Surgery and Nephrectomy
IRAS ID
246513
Contact name
Ruchika Kohli
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
1 years, 7 months, 11 days
Research summary
Patients with end stage renal disease, who are candidates for kidney transplant, are categorised as a moderate risk group for the development of clot formation and, like with other major surgical procedures, are recommended to receive routine preventive anticoagulation treatment post-surgery.
However, because end stage renal disease results in a complex alteration of the clotting system, these patients are at increased risk of both clotting and bleeding. Data within literature as to the exact changes that occur in the clotting system peri-transplant are sparse, and as a result the optimal approach as to the type and duration of anticoagulation is not clearly understood in these patients.
We will study two groups of patients, kidney transplant recipients and donors, to evaluate changes in clotting parameters at specific time points pre and post surgery.
We aim to recruit 50 kidney transplant recipients and 50 renal transplant donors already awaiting to undergo surgery at the renal unit of the Royal London Hospital and seek their permission to take additional blood samples (not exceeding 15mls)for further evaluation of their clotting system. These blood samples will be taken at the same time as routine samples, where possible, therefore not requiring additional needles.
The recipients' and donors' management will not change, but as a result of this study, we will improve our understanding of the role of different clotting parameters and assays in assessing the use of anticoagulant treatment in this cohort of patients.
Lay Results:
Patients with chronic kidney disease (CKD) have imbalanced haemostasis which causes them to be at increased risk of both thrombosis and bleeding. Renal transplant surgery further increases these risks in the short-term. Current NICE guidance recommends that pharmacological thromboprophylaxis should be administered to these patients post-operatively but the evidence for this recommendation is not specific to renal transplant surgery. Providing optimal pharmacological thromboprophylaxis for these patients after surgery is a fine balance between preventing thrombosis on one hand and avoiding bleeding on the other: both these complications can have detrimental outcome for the recipient with loss of donated graft.
The specific aims of this thesis were to (1) review and evaluate the literature on effectiveness and safety of pharmacological thromboprophylaxis in renal transplant recipients (2) understand the current practice for routine pharmacological thromboprophylaxis across renal transplant units within the UK and (3) determine if improvement in renal function post renal transplant surgery corrected the haemostatic imbalance induced by chronic renal disease in renal transplant recipients.
The results of this systematic review showed lack of good quality studies to determine whether pharmacological thromboprophylaxis compared to no thromboprophylaxis or another thromboprophylaxis was efficacious and safe for patients undergoing renal transplantation surgery.
The national survey data demonstrated universal use of thromboprophylaxis in renal transplant recipients with low molecular weight heparin being the most popular choice of anticoagulant in non-high-risk patients. However, there was uncertainty on when to initiate thromboprophylaxis and what the optimal duration and choice of anticoagulant was in patients categorised as high risk for thrombosis.
Fifty-two patients (28 recipients and 24 donors) were studied (1) pre-operatively (2) immediately post-transplant (3) 24 hours post-transplant and in the case of recipients only (4) 72 hours post-transplant and (5) 120 hours post renal transplant. The results showed significant differences in haemostatic parameters between recipients and donors in the early post-op period and, although the initial pattern of change in the immediate post-op period was similar, the persistence of a hypercoagulable state was obvious in recipients, despite recovery in renal function and initiation of thromboprophylaxis.
Renal transplant recipients remain prothrombotic in the early post-operative period despite early initiation of pharmacological thromboprophylaxis and improvement in renal function. There is need to determine whether thromboprophylaxis in these patients needs to be extended beyond the immediate post-operative phase and what the optimal duration of thromboprophylaxis should be.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0390
Date of REC Opinion
4 Jun 2018
REC opinion
Favourable Opinion