Effects of Heparin on Arteriovenous Fistula Patency

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.

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Key information

Conditions

Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic Kidney Disease, In need of AVF placement

Exclusion criteria

Contraindications for anticoagulant therapy

Treatment and study plan

Heparin

Drug

100units/kg of heparin were administered for the case group after dissection prior to anastomosis.

Other names: Case

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.

Sponsors and collaborators

Lead sponsor

Fatemeh Hoseinzadegan

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Jul 9, 2015
Registry last updated: Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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