Hemodialysis Patients Clinical Trial
The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV
graft thromboses in patients on chronic hemodialysis.
Primary efficacy end point of the study: to compare the time of onset of a new thrombotic
event after successful angiography of the AV graft.
Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following
a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on
chronic hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body
weight per day or control group (not on Clexane). Patients will be followed for a year or
till next AV graft thrombotic occlusion, if it occurs before. In both groups we will compare
time periods in months between first and recurrent thrombotic events of AVG by evaluation
the difference between two sample means. Also interim analysis of AV grafts patency between
the two groups will be evaluated at different time points: three, six and twelve months
after randomization. Patients in both groups will receive unfractionated heparin during
dialysis session to prevent thrombosis of extracorporeal circulation. Patients from
Enoxaparin group will receive a half dose (500 units/hour) to prevent possible risk of
bleeding during the session. Before randomization all patients will be evaluated for
hypercoagulability state which will include: Factor V Laden deficiency, Anti phospholipid
antibodies (APLA), Antithrombin III deficiency and Protein C/S deficiency.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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