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

NCT ID: NCT01970280

Last Updated: 2013-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enoxaparin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Sidney Ben Chetrit

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sidney Ben Chetrit

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Nephrology and Hypertension, Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Helsinki committee

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilan Rozenberg, MD

Role: CONTACT

ilan.rozenberg@clalit.org.il

+97297471734

Facility Contacts

Role: primary

+972-9-7471588

Role: primary

+972-9-7471588

Other Identifiers

0146-13-MMC

Identifier Type: OTHER

Identifier Source: secondary_id

0146-13-MMC

Identifier Type: -

Identifier Source: org_study_id