CClinicalTrials.gg
Status unknownNCT01970280Updated Oct 28, 2013

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

A Phase 4 interventional study of Enoxaparin in Hemodialysis Patients, sponsored by Dr. Sidney Ben Chetrit. Status unknown at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-28.

Sponsored by Dr. Sidney Ben Chetrit · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemodialysis Patients
03

In context

Lead sponsor

This is the only study on the registry with Dr. Sidney Ben Chetrit as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • hemodialysis patients ≥ 18 years of age after occurrence of AVG thrombosis and successful thrombolysis/thrombectomy with angioplasty.

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • 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

Interventions

  • DrugEnoxaparin
06

What researchers measure

Primary outcomes

  1. To compare the time of onset of a new thrombotic event after successful angiography of the AV graft.

    Time frame: 1 y

07

Study locations

2 of 2 sites recruiting
  • Department of Nephrology and Hypertension, Meir Medical Center
    Kfar Sava, Israel
    • · Contact · +972-9-7471588
    • Sudney BenChetrit, MD · Principal investigator
    Recruiting
  • Helsinki committee
    Kfar Sava, Israel
    • · Contact · +972-9-7471588
    • Sidney BenChetrit, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01970280
Lead sponsor
Dr. Sidney Ben Chetrit
Responsible party
Dr. Sidney Ben Chetrit (MD, Meir Hospital, Kfar Saba, Israel) — Sponsor-investigator
First posted
Oct 28, 2013
Start date
Sep 2013
Primary completion
Nov 2014 (estimated)
Completion
Jan 2015 (estimated)
Last update
Oct 28, 2013

Study contacts

Ilan Rozenberg, MD
Contact
ilan.rozenberg@clalit.org.il
+97297471734
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion