NCT02493504

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

July 1, 2015

Last Update Submit

July 7, 2015

Conditions

Arteriovenous Fistula

Keywords

Heparin

Outcome Measures

Primary Outcomes (1)

  • 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.

    The first 24 hours after anostomosis

Study Arms (2)

Heparin

EXPERIMENTAL

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

Drug: Heparin

Control

NO INTERVENTION

75 received no intraoperative heparin injection.

Interventions

HeparinDRUG

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

Also known as: Case
Heparin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Kidney Disease, In need of AVF placement

You may not qualify if:

  • Contraindications for anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • 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.

    PMID: 18405348BACKGROUND

  • 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.

    PMID: 12234281BACKGROUND

  • 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.

    PMID: 1147768BACKGROUND

  • 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.

    PMID: 14727162BACKGROUND

  • 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.

    PMID: 15011176BACKGROUND

  • Green LD, Lee DS, Kucey DS. A metaanalysis comparing surgical thrombectomy, mechanical thrombectomy, and pharmacomechanical thrombolysis for thrombosed dialysis grafts. J Vasc Surg. 2002 Nov;36(5):939-45. doi: 10.1067/mva.2002.127524.

    PMID: 12422093BACKGROUND

  • Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012 Mar;55(3):849-55. doi: 10.1016/j.jvs.2011.07.095. Epub 2011 Nov 8.

    PMID: 22070937BACKGROUND

  • Erkut B, Unlu Y, Ceviz M, Becit N, Ates A, Colak A, Kocak H. Primary arteriovenous fistulas in the forearm for hemodialysis: effect of miscellaneous factors in fistula patency. Ren Fail. 2006;28(4):275-81. doi: 10.1080/08860220600583617.

    PMID: 16771241BACKGROUND

  • Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.

    PMID: 18477783BACKGROUND

  • Ghorbani A, Aalamshah M, Shahbazian H, Ehsanpour A, Aref A. Randomized controlled trial of clopidogrel to prevent primary arteriovenous fistula failure in hemodialysis patients. Indian J Nephrol. 2009 Apr;19(2):57-61. doi: 10.4103/0971-4065.53323.

    PMID: 20368925BACKGROUND

  • Akin EB, Topcu O, Ozcan H, Ersoz S, Aytac S, Anadol E. Hemodynamic effect of transdermal glyceryl trinitrate on newly constructed arteriovenous fistula. World J Surg. 2002 Oct;26(10):1256-9. doi: 10.1007/s00268-002-6515-1. Epub 2002 Sep 4.

    PMID: 12205547BACKGROUND

  • Tessitore N, Bedogna V, Poli A, Mantovani W, Lipari G, Baggio E, Mansueto G, Lupo A. Adding access blood flow surveillance to clinical monitoring reduces thrombosis rates and costs, and improves fistula patency in the short term: a controlled cohort study. Nephrol Dial Transplant. 2008 Nov;23(11):3578-84. doi: 10.1093/ndt/gfn275. Epub 2008 May 29.

    PMID: 18511608BACKGROUND

  • Sharathkumar A, Hirschl R, Pipe S, Crandell C, Adams B, Lin JJ. Primary thromboprophylaxis with heparins for arteriovenous fistula failure in pediatric patients. J Vasc Access. 2007 Oct-Dec;8(4):235-44.

    PMID: 18161668BACKGROUND

  • Bhomi KK, Shrestha S, Bhattachan CL. Role of systemic anticoagulation in patients undergoing vascular access surgery. Nepal Med Coll J. 2008 Dec;10(4):222-4.

    PMID: 19558057BACKGROUND

  • D'Ayala M, Smith RM, Martone C, Briggs W, Deitch JS, Wise L. The effect of systemic anticoagulation in patients undergoing angioaccess surgery. Ann Vasc Surg. 2008 Jan;22(1):11-5. doi: 10.1016/j.avsg.2007.09.002. Epub 2007 Dec 4.

    PMID: 18055171BACKGROUND

  • Wang BR, Rowe VL, Ham SW, Han S, Patel K, Weaver FA, Woo K. A prospective clinical evaluation of the effects of intraoperative systemic anticoagulation in patients undergoing arteriovenous fistula surgery. Am Surg. 2010 Oct;76(10):1112-4. doi: 10.1177/000313481007601020.

    PMID: 21105622BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Heparin

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Mohammad Mozafar, M.D.

    Associate Professor of General and Vascular Surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 9, 2015

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

January 1, 2013

Last Updated

July 9, 2015

Record last verified: 2015-07