Coagulation in Critical Care
Research type
Research Study
Full title
A prospective observational study of the effect of Acute Kidney Injury on both the pharmacodynamics of low molecular weight heparin venous-thromboembolism prophylaxis and the coagulation diathesis in critically ill patients
IRAS ID
161107
Contact name
Suzanne Forbes
Contact email
Sponsor organisation
Director of Research Services & Business Development, Joint Research Management Office
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Patients who are very unwell, requiring more intensive treatment and monitoring, are admitted to the adult critical care unit (ACCU). Often their illness affects many organs, frequently related to severe uncontrolled infection (sepsis). It is known that these patients develop dysfunction of their clotting system; they are at increased risk of bleeding but also paradoxically at increased risk of clotting. Because of the increased risk of clotting they are prescribed anti-clotting medication (anticoagulation) as per national guidelines. This medication is most often in the form of low molecular weight heparin (LMWH).
In addition many of these patients also have a sudden deterioration in their kidney function (acute kidney injury, AKI) to varying levels. This also interferes with the blood's ability to clot appropriately. Little is understood about how anticoagulation medications affects patients’ clotting in patients in ACCU, and whether deterioration in kidney function alters this.
Current practice is to reduce the dose of LMWH in patients with kidney impairment with little evidence of the necessity or effect of this. Moreover, standard clotting tests are not well correlated with an individual’s risk of bleeding or clotting. Recently newer tests have been developed which may allow a more accurate understanding of the clotting abnormalities in these patients.
This study aims to do two things. Firstly to describe in detail the clotting abnormalities seen in patients in the ACCU with and without AKI using standard and novel tests of clotting. Secondly to map out the drug levels seen after giving LMWH to patients with and without AKI to better understand how kidney function affects this, and whether dose adjustment is necessary. This will be done observationally, testing patients already on the ACCU, comparing them with an ACCU 'control' group of patients with isolated head injuries and normal kidney function, .
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
15/LO/0660
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion