Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
- To compare the time of onset of a new thrombotic event after successful angiography of the AV graft. [ Time Frame: 1 y ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Enoxaparin
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).
|No Intervention: Observation|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970280
|Department of Nephrology and Hypertension, Meir Medical Center|
|Kfar Sava, Israel|
|Kfar Sava, Israel|