DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Low Molecular Weight Heparin for Hemodialysis Anticoagulation

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Failure on Dialysis

Intervention: low molecular weight heparin (enoxaparin sodium) (Drug); standard unfractionated heparin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Tehran University of Medical Sciences

Summary

Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as anticoagulation during hemodialysis (HD) therapy. In this study the investigators have compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.

Clinical Details

Official title: Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection

Secondary outcome: changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid.

Detailed description: In this prospective, randomized, cross-over study the investigators compared the safety, clinical efficacy of Clexane (enoxaparin sodium; Sanofi-Aventis) with unfractionated heparin in 27 chronic HD patients. Group A received Clexane (enoxaparin sodium; Sanofi-Aventis) and were followed up for 3 months and then crossed over to Unfractionated heparin for a further 3-month period. Group B received Unfractionated heparin first and then crossed over to Clexane, each followed up for 3 months. Heparin anticoagulation, clinical clotting and hemorrhage were evaluated by visual inspection after blood draining of the air trap.

Eligibility

Minimum age: 25 Years. Maximum age: 76 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients in end stage renal failure requiring maintenance dialysis were recruited

into the study Exclusion Criteria:

- Patients with known bleeding disorders

- Subjects receiving oral or other forms of anticoagulant therapy (e. g. warfarin,

aspirin) or drugs that could affect heparin activity (e. g. digitalis, tetracyclines, and antihistamines) were also excluded. Subjects continued their usual medication (including lipid-lowering therapy ) and were treated in the normal manner by their caring physicians during the study.

Locations and Contacts

Additional Information

Starting date: March 2011
Last updated: May 18, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017