Effects of Heparin on Arteriovenous Fistula Patency
Primary Purpose
Arteriovenous Fistula
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Heparin
Sponsored by
About this trial
This is an interventional prevention trial for Arteriovenous Fistula focused on measuring Heparin
Eligibility Criteria
Inclusion Criteria:
- Chronic Kidney Disease, In need of AVF placement
Exclusion Criteria:
- Contraindications for anticoagulant therapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Heparin
Control
Arm Description
75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis.
75 received no intraoperative heparin injection.
Outcomes
Primary Outcome Measures
The number of patients with a bruit auscultated over AVF
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02493504
Brief Title
Effects of Heparin on Arteriovenous Fistula Patency
Official Title
Effects of Heparin on Early Patency of Arteriovenous Fistula in Angioaccess Surgery of Patients With End-Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatemeh Hoseinzadegan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
Keywords
Heparin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heparin
Arm Type
Experimental
Arm Description
75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis.
Arm Title
Control
Arm Type
No Intervention
Arm Description
75 received no intraoperative heparin injection.
Intervention Type
Drug
Intervention Name(s)
Heparin
Other Intervention Name(s)
Case
Intervention Description
100units/kg of heparin were administered for the case group after dissection prior to anastomosis.
Primary Outcome Measure Information:
Title
The number of patients with a bruit auscultated over AVF
Description
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.
Time Frame
The first 24 hours after anostomosis
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic Kidney Disease, In need of AVF placement
Exclusion Criteria:
Contraindications for anticoagulant therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Mozafar, M.D.
Organizational Affiliation
Associate Professor of General and Vascular Surgery
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
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Citation
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Citation
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Effects of Heparin on Arteriovenous Fistula Patency
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