Low Molecular Weight Heparin for Hemodialysis Anticoagulation
|ClinicalTrials.gov Identifier: NCT01356615|
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Failure on Dialysis||Drug: low molecular weight heparin (enoxaparin sodium) Drug: standard unfractionated heparin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
enoxaparin sodium (Clexane) (40 mg) followed prospectively for 3 months (36 dialyses)
Drug: low molecular weight heparin (enoxaparin sodium)
Enoxaparin sodium (Clexane; 40 mg) was administered 3-4 min before dialysis as a bolus dose, into the arterial line pre-dialyzer.
Active Comparator: standard unfractionated heparin
standard unfractionated heparin followed prospectively for 3 months (36 dialyses)
Drug: standard unfractionated heparin
Heparin (sodium heparin 5000 IU/ml) was administered as a bolus dose (50 IU/kg body weight) intravenously into the pre-dialyzer arterial line of the extracorporeal blood circuit, followed by a maintenance dose of 1000 IU sodium heparin per hour.
- Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection [ Time Frame: 3 month ]
The frequency and degree of clot and fibrin formation in both the dialyzer and lines were scored on a 10-point scale, with 1 indicating no clot formation and 10 sever clotting or total occlusion. This assessment was done after the blood had been returned to the patient by flushing the dialyzer and lines with normal saline. Hemorrhage or thrombosis, during and between dialyses was also noted. Heparin anticoagulation, Clinical clotting and Hemorrhage were evaluated by visual inspection.
Hemorrhages were categorized as weak, moderate, and severe.
- changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid. [ Time Frame: 3 month ]27 chronic HD patients. They were randomly assigned to either Clexane (40 mg) or standard heparin, and followed prospectively for 3 months (36 dialyses) and then crossed over to the alternate therapy for a further 3 months Fasting standard lipid profiles were determined at the end of each arm of the study. Total cholesterol (TC), high density lipoprotein (HDL), and triglyceride (TG) were measured.