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

This study is currently recruiting participants.
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
  Purpose

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 Intervention Phase
Hemodialysis Patients
Drug: Enoxaparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Meir Hospital, Kfar Saba, Israel:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 26
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970280

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

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

No publications provided

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
Study First Received: October 22, 2013
Last Updated: October 25, 2013
Health Authority: Israel: Israel ministry of health

Additional relevant MeSH terms:
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014