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Clinical Trials/NCT02493504
NCT02493504
Completed
Phase 4

Effects of Heparin on Early Patency of Arteriovenous Fistula in Angioaccess Surgery of Patients With End-Stage Renal Disease

Fatemeh Hoseinzadegan0 sites150 target enrollmentJanuary 2011
InterventionsHeparin
DrugsHeparin

Overview

Phase
Phase 4
Intervention
Heparin
Conditions
Arteriovenous Fistula
Sponsor
Fatemeh Hoseinzadegan
Enrollment
150
Primary Endpoint
The number of patients with a bruit auscultated over AVF
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Arteriovenous fistula (AVF) is now the optimal method of obtaining vascular access for dialysis. Measures such as systemic anticoagulation have been proposed as means of increasing patency rates but enough evidence does not exist to support their use. The investigators aimed to evaluate the efficacy of preoperative heparin injection on patency of AVF during the first 24 hours after surgery and to determine whether such measure can be used to prevent early thrombosis of the vascular access.

Detailed Description

The study was carried out on patients admitted to Shohada-e-Tajrish hospital for permanent vascular access placement since April 2011 through September 2012. The exclusion criteria consisted of having a contraindication of administration of anticuagulant agent. 150 patients were enrolled in the study. All patients were operated on by a single surgeon (Dr Mozafar. The non dominant upper extremity (mostly the left arm) was generally used unless unfavorable vasculature or previous fistula placement changed the preference. The anastomosis technique was either end-to-side or side-to-side using a number 6.0 prolene suture. 75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis while the other 75 received no intraoperative heparin injection. Auscultation of bruit and palpation of thrill was used to assess arteriovenous fistula patency in the first 24 hours after AVF placement. Data analysis was performed using SPSS v.20. A p-value of less than 0.05 was considered as statistically significant. Bivariate analysis in the form of Chi-square tests, T-test and Fischer's exact test were calculated. Patient enrollment was voluntary and no costs were imposed on the patients. The study protocol was in accordance with 1975 Declaration of Helsinki.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
January 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fatemeh Hoseinzadegan
Responsible Party
Sponsor Investigator
Principal Investigator

Fatemeh Hoseinzadegan

Dr.

Shahid Beheshti University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • Chronic Kidney Disease, In need of AVF placement

Exclusion Criteria

  • Contraindications for anticoagulant therapy

Arms & Interventions

Heparin

75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis.

Intervention: Heparin

Outcomes

Primary Outcomes

The number of patients with a bruit auscultated over AVF

Time Frame: The first 24 hours after anostomosis

Hearing a bruit through auscultation over the AVF is regarded as a positive measure or in other words a patent AVF. The frequency of positive measures are compared between the two groups.

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