Effects of Heparin on Arteriovenous Fistula Patency

Phase 4

Completed

• Conditions: Arteriovenous Fistula
• Interventions: Drug: Heparin

• Registration Number: NCT02493504
• Lead Sponsor: Fatemeh Hoseinzadegan

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-04
• Study Completion: 2013-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-07
• Last Update Submitted: 2015-07-07
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Chronic Kidney Disease, In need of AVF placement

Exclusion Criteria

• Contraindications for anticoagulant therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The number of patients with a bruit auscultated over AVF	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.