Effects of Heparin on Arteriovenous Fistula Patency

Arteriovenous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493504
• Other study ID #: SHBMU-001124
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2015
• Last updated: July 7, 2015
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2015
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Chronic Kidney Disease, In need of AVF placement

Exclusion Criteria:

• Contraindications for anticoagulant therapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fatemeh Hoseinzadegan

References & Publications (16)

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. Review. — View Citation

Akin EB, Topçu O, Ozcan H, Ersöz S, Aytaç S, Anadol E. Hemodynamic effect of transdermal glyceryl trinitrate on newly constructed arteriovenous fistula. World J Surg. 2002 Oct;26(10):1256-9. Epub 2002 Sep 4. — View Citation

Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. Review. — View Citation

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. — View Citation

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. Epub 2007 Dec 4. — View Citation

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. — View Citation

Erkut B, Unlü Y, Ceviz M, Becit N, Ates A, Colak A, Koçak H. Primary arteriovenous fistulas in the forearm for hemodialysis: effect of miscellaneous factors in fistula patency. Ren Fail. 2006;28(4):275-81. — View Citation

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. — View Citation

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. — View Citation

Haimov M, Baez A, Neff M, Slifkin R. Complications of arteriovenous fistulas for hemodialysis. Arch Surg. 1975 Jun;110(6):708-12. — View 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. Epub 2004 Jan 20. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View 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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No