We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Dr. Sidney Ben Chetrit, Meir Hospital, Kfar Saba, Israel.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970280
First Posted: October 28, 2013
Last Update Posted: October 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Sidney Ben Chetrit, Meir Hospital, Kfar Saba, Israel
October 22, 2013
October 28, 2013
October 28, 2013
September 2013
November 2014   (Final data collection date for primary outcome measure)
To compare the time of onset of a new thrombotic event after successful angiography of the AV graft. [ Time Frame: 1 y ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hemodialysis Patients
Drug: Enoxaparin
  • 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).
    Intervention: Drug: Enoxaparin
  • No Intervention: Observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
26
January 2015
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01970280
0146-13-MMC
0146-13-MMC ( Other Identifier: Meir Medical Center, Nephrology and hypertension department, Kfar Sava, Israel )
Not Provided
Not Provided
Not Provided
Dr. Sidney Ben Chetrit, Meir Hospital, Kfar Saba, Israel
Dr. Sidney Ben Chetrit
Not Provided
Not Provided
Meir Hospital, Kfar Saba, Israel
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
To Top