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Effects of Heparin on Arteriovenous Fistula Patency

Primary Purpose

Arteriovenous Fistula

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Heparin
Sponsored by
Fatemeh Hoseinzadegan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arteriovenous Fistula focused on measuring Heparin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 1, 2015
    Last Updated
    July 7, 2015
    Sponsor
    Fatemeh Hoseinzadegan
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    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:
    PubMed Identifier
    18405348
    Citation
    Zhang QL, Rothenbacher D. Prevalence of chronic kidney disease in population-based studies: systematic review. BMC Public Health. 2008 Apr 11;8:117. doi: 10.1186/1471-2458-8-117.
    Results Reference
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    PubMed Identifier
    12234281
    Citation
    Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.
    Results Reference
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    PubMed Identifier
    1147768
    Citation
    Haimov M, Baez A, Neff M, Slifkin R. Complications of arteriovenous fistulas for hemodialysis. Arch Surg. 1975 Jun;110(6):708-12. doi: 10.1001/archsurg.1975.01360120026004. No abstract available.
    Results Reference
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    PubMed Identifier
    14727162
    Citation
    Perera GB, Mueller MP, Kubaska SM, Wilson SE, Lawrence PF, Fujitani RM. Superiority of autogenous arteriovenous hemodialysis access: maintenance of function with fewer secondary interventions. Ann Vasc Surg. 2004 Jan;18(1):66-73. doi: 10.1007/s10016-003-0094-y. Epub 2004 Jan 20.
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    PubMed Identifier
    15011176
    Citation
    Abularrage CJ, Sidawy AN, Weiswasser JM, White PW, Arora S. Medical factors affecting patency of arteriovenous access. Semin Vasc Surg. 2004 Mar;17(1):25-31. doi: 10.1053/j.semvascsurg.2003.11.006.
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    PubMed Identifier
    12422093
    Citation
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    PubMed Identifier
    22070937
    Citation
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    PubMed Identifier
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    Citation
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    Effects of Heparin on Arteriovenous Fistula Patency

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