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

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 Overview

• Status: Unknown
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Drug: Enoxaparin

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Kfar Sava, Israel
    • Recruiting
    • Department of Nephrology and Hypertension, Meir Medical Center
    • Contact: Phone Number: +972-9-7471588
    • Principal Investigator: Sudney BenChetrit, MD
  • Kfar Sava, Israel
    • Recruiting
    • Helsinki committee
    • Contact: Phone Number: +972-9-7471588
    • Principal Investigator: Sidney BenChetrit, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Observation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the time of onset of a new thrombotic event after successful angiography of the AV graft.	1 y

Collaborators and Investigators

• Sponsor: Dr. Sidney Ben Chetrit

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ANTICIPATED): November 1, 2014
• Study Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (ESTIMATE): October 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2013
• Last Update Submitted That Met QC Criteria: October 25, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: 0146-13-MMC (OTHER: Meir Medical Center, Nephrology and hypertension department, Kfar Sava, Israel)