Low Molecular Weight Heparin for Hemodialysis Anticoagulation

End Stage Renal Failure on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356615
• Other study ID #: 814
• Secondary ID: enoxaparin sodiu
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: May 18, 2011
• Start date: March 2011
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: 1. Iran: Department of Nephrology and Dialysis, Imam Khomeini Hospital. Tehran University of Medical Sciences, Tehran.2. Iran: Department of Nephrology and Dialysis, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran.3. Iran: Research Deputy of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran.
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 76 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection	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.	3 month	Yes
Secondary	changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid.	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.	3 month	Yes