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

NCT01970280 | Unknown Phase 4

• 1 other identifier: 0146-13-MMC
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemodialysis Patients

Outcome Measures

Primary Outcomes (1)

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

  1 y

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

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

Observation

NO INTERVENTION

Interventions

Enoxaparin DRUG

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known allergy to enoxaparin
• Persistent systolic blood pressure 180 or more and/or persistent diastolic blood pressure 100 or more
• Chronic Warfarin treatment
• Double antiagregant treatment (aspirin plus clopidogrel)
• Platelets count below 80000/µl
• Known HIT (Heparin Induced Thrombocytopenia)
• Recent bleeding (\<2 weeks)
• Recent stroke (\<4 weeks)
• Reduced mental status and inability to give informed consent

Sponsors & Collaborators

• Dr. Sidney Ben Chetrit: lead

Study Sites (2)

Department of Nephrology and Hypertension, Meir Medical Center

Kfar Saba, Israel

RECRUITING

Helsinki committee

Kfar Saba, Israel

RECRUITING

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Ilan Rozenberg, MD

CONTACT

+97297471734; ilan.rozenberg@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 28, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 28, 2013

Record last verified: 2013-10

Locations

IL (2)