Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Meir Hospital, Kfar Saba, Israel
Sponsor:
Information provided by (Responsible Party):
Dr. Sidney Ben Chetrit, Meir Hospital, Kfar Saba, Israel
ClinicalTrials.gov Identifier:
NCT01970280
First received: October 22, 2013
Last updated: October 25, 2013
Last verified: October 2013

October 22, 2013
October 25, 2013
September 2013
November 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01970280 on ClinicalTrials.gov Archive Site
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Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.
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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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hemodialysis Patients
Drug: Enoxaparin
  • 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).
    Intervention: Drug: Enoxaparin
  • No Intervention: Observation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
January 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ilan Rozenberg, MD +97297471734 ilan.rozenberg@clalit.org.il
Israel
 
NCT01970280
0146-13-MMC, 0146-13-MMC
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Dr. Sidney Ben Chetrit, Meir Hospital, Kfar Saba, Israel
Dr. Sidney Ben Chetrit
Not Provided
Not Provided
Meir Hospital, Kfar Saba, Israel
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP