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

Hemodialysis Patients Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01970280
• Other study ID #: 0146-13-MMC
• Secondary ID: 0146-13-MMC
• Status: Recruiting
• Phase: Phase 4
• First received: October 22, 2013
• Last updated: October 25, 2013
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2013
• Source: Meir Hospital, Kfar Saba, Israel
• Contact: Ilan Rozenberg, MD
• Phone: +97297471734
• Email: ilan.rozenberg[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Israel ministry of health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Drug:
• Enoxaparin

Locations

Country	Name	City	State
Israel	Department of Nephrology and Hypertension, Meir Medical Center	Kfar Sava
Israel	Helsinki committee	Kfar Sava

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sidney Ben Chetrit

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the time of onset of a new thrombotic event after successful angiography of the AV graft.		1 y	Yes