Hemodialysis Patients
Conditions
Brief summary
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.
Interventions
DRUGEnoxaparin
Sponsors
Dr. Sidney Ben Chetrit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hemodialysis patients ≥ 18 years of age after occurrence of AVG thrombosis and successful thrombolysis/thrombectomy with angioplasty.
Exclusion criteria
1. Known allergy to enoxaparin 2. Persistent systolic blood pressure 180 or more and/or persistent diastolic blood pressure 100 or more 3. Chronic Warfarin treatment 4. Double antiagregant treatment (aspirin plus clopidogrel) 5. Platelets count below 80000/µl 6. Known HIT (Heparin Induced Thrombocytopenia) 7. Recent bleeding (\<2 weeks) 8. Recent stroke (\<4 weeks) 9. Reduced mental status and inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time of onset of a new thrombotic event after successful angiography of the AV graft. | 1 y |
Countries
Israel
Contacts
Primary ContactIlan Rozenberg, MD
Outcome results
None listed