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

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ClinicalTrials.gov Identifier: NCT01970280
Recruitment Status : Unknown
Verified October 2013 by Dr. Sidney Ben Chetrit, Meir Hospital, Kfar Saba, Israel.
Recruitment status was:  Recruiting
First Posted : October 28, 2013
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Sidney Ben Chetrit, Meir Hospital, Kfar Saba, Israel

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.


Condition or disease Intervention/treatment Phase
Hemodialysis Patients Drug: Enoxaparin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : September 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).
Drug: Enoxaparin
No Intervention: Observation



Primary Outcome Measures :
  1. To compare the time of onset of a new thrombotic event after successful angiography of the AV graft. [ Time Frame: 1 y ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970280


Contacts
Contact: Ilan Rozenberg, MD +97297471734 ilan.rozenberg@clalit.org.il

Locations
Israel
Department of Nephrology and Hypertension, Meir Medical Center Recruiting
Kfar Sava, Israel
Contact    +972-9-7471588      
Principal Investigator: Sudney BenChetrit, MD         
Helsinki committee Recruiting
Kfar Sava, Israel
Contact    +972-9-7471588      
Principal Investigator: Sidney BenChetrit, MD         
Sponsors and Collaborators
Dr. Sidney Ben Chetrit

Responsible Party: Dr. Sidney Ben Chetrit, MD, Meir Hospital, Kfar Saba, Israel
ClinicalTrials.gov Identifier: NCT01970280     History of Changes
Other Study ID Numbers: 0146-13-MMC
0146-13-MMC ( Other Identifier: Meir Medical Center, Nephrology and hypertension department, Kfar Sava, Israel )
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action