NCT07559942

Brief Summary

End-stage renal disease (ESRD) is a growing global health burden, and the creation of a native arteriovenous fistula (AVF) is the gold standard for vascular access in patients requiring hemodialysis \[1\]. AVFs offer superior longevity, fewer infectious complications, and lower mortality rates compared to central venous catheters or synthetic grafts \[2\]. However, a significant limitation to their widespread success is the high rate of early failure, primarily due to failure to mature (FTM). FTM occurs in 20-40% of AVFs, rendering them unusable for dialysis \[3\]. Apixaban, a direct factor Xa inhibitor, offers a potential advantage by providing sustained anticoagulation throughout the critical maturation period \[7\]. Its predictable pharmacokinetics, oral administration, and favorable safety profile make it an attractive agent for short-term use in this setting \[8\]. By reducing microthrombotic events during the first 4-6 weeks following AVF creation, apixaban could potentially improve maturation rates. However, this potential benefit must be weighed against the increased risk of bleeding, hematoma formation, and wound complications that could negatively impact fistula maturation \[9\].

Trial Health

77
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress90%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

April 24, 2026

Last Update Submit

May 2, 2026

Conditions

Endstage Renal DiseaseDirect Oral Anticoagulants (DOACs)Arteriovenous FistulaArteriovenous Fistula Occlusion

Keywords

arteriovenous fistulamaturationanticoagulationdirect oral anticoagulants

Outcome Measures

Primary Outcomes (1)

  • AV Fistula Maturation

    As per standard definitions

    Six weeks from index operation

Study Arms (2)

Apiban group

EXPERIMENTAL

Apiban 2.5mg BD

Drug: Apixaban

Non-Apiban group

NO INTERVENTION

No Apiban given

Interventions

ApixabanDRUG

Apixaban 2.5mg BD given postoperatively for 6 weeks to intervention arm

Also known as: anticoagulant, DOACs, Apiban
Apiban group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Diagnosis of ESRD (eGFR \< 15 mL/min/1.73m² or already on dialysis) with plans for hemodialysis.
  • Planned primary upper extremity AVF creation (radiocephalic, brachiocephalic, or brachiobasilic).
  • Suitable vessels on preoperative duplex ultrasound (artery ≥ 2 mm, vein ≥ 2.5 mm without tourniquet).
  • Ability to provide informed consent.

You may not qualify if:

  • Known bleeding diathesis or hypercoagulable state.
  • Current therapeutic anticoagulation (any indication).
  • Current dual antiplatelet therapy.
  • History of intracranial hemorrhage.
  • Known allergy or hypersensitivity to apixaban.
  • Inability to comply with study protocol or follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital, Lahore

Lahore, Punjab Province, 54300, Pakistan

RECRUITING

Related Publications (17)

  • Wang BR, Rowe VL, Ham SW, et al. A prospective clinical evaluation of the effects of intraoperative systemic anticoagulation in patients undergoing arteriovenous fistula surgery. Am Surg. 2010;76(10):1112-1114.

    BACKGROUND

  • Bhomi KK, Shrestha S, Bhattachan CL. Role of systemic anticoagulation in patients undergoing vascular access surgery. Nepal Med Coll J. 2008;10(4):222-224.

    BACKGROUND

  • Ebrahimifard F. Effect of intraoperative intravenous injection of heparin on patency rate of radiocephalic autogenous arteriovenous fistula in chronic renal failure patients. Arch Crit Care Med. 2015;1(2):e1528.

    BACKGROUND

  • Mozafar M, Hoseinzadegan F, Lotfollahzadeh S, et al. Effects of heparin on early patency of arteriovenous fistula in angioaccess surgery of patients with end-stage renal disease. Intern Med Med Investig J. 2018;3(1):36.

    BACKGROUND

  • Aimanan K, Idris M, Suryani L, et al. Does systemic heparin reduce thrombosis rate of radiocephalic fistula: double-blinded randomized study. Vasc Dis Ther. 2017;2(6):1-5.

    BACKGROUND

  • Douketis JD, Spyropoulos AC. Perioperative management of patients taking direct oral anticoagulants: a review. JAMA. 2024;332(10):825.

    BACKGROUND

  • Bristol-Myers Squibb, Pfizer. Eliquis® (apixaban) prescribing information. 2024.

    BACKGROUND

  • Ravari H, Kazemzade GH, Sarookhani A, Khashayar P. Effect of heparin on the patency of arteriovenous fistula. Acta Med Iran. 2008;46(5):379-382.

    BACKGROUND

  • D'Ayala M, Smith R, Martone C, Briggs W, Deitch JS, Wise L. The effect of systemic anticoagulation in patients undergoing angioaccess surgery. Ann Vasc Surg. 2008;22(1):11-15.

    BACKGROUND

  • Steffel J, Verhamme P, Potpara TS, et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-1393.

    BACKGROUND

  • Byon W, Garonzik S, Boyd RA, Frost CE. Apixaban: A clinical pharmacokinetic and pharmacodynamic review. Clin Pharmacokinet. 2019;58(10):1265-1279.

    BACKGROUND

  • Bahi M. Effect of systemic intraoperative heparin use on upper extremity arteriovenous fistula patency in end-stage renal disease patients. Scientific World Journal. 2021;2021:2965743.

    BACKGROUND

  • Smith GE, Souroullos P, Cayton T, Harwood A, Carradice D, Chetter IC. A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis. J Vasc Access. 2016;17(1):1-5.

    BACKGROUND

  • Rothuizen TC, Wong C, Quax PH, van Zonneveld AJ, Rabelink TJ, Rotmans JI. Arteriovenous access failure: more than just intimal hyperplasia? Nephrol Dial Transplant. 2013;28(5):1085-1092.

    BACKGROUND

  • Dember LM, Beck GJ, Allon M, et al. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008;299(18):2164-2171.

    BACKGROUND

  • Quencer KB, Arici M. Arteriovenous fistulas and their characteristic sites of stenosis. AJR Am J Roentgenol. 2015;205(4):726-734.

    BACKGROUND

  • Malovrh M. Strategy for the maximal use of native arteriovenous fistulae for hemodialysis. Scientific World Journal. 2006;6:808-815.

    BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

apixabanAnticoagulants

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)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Muhammad Irfan Khan, Vascular Sur

    Combined military hospital lahore

    STUDY CHAIR

Central Study Contacts

Muhammad Kashif, FCPS Surgery

CONTACT

00923219698888kashiramzan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

April 30, 2026

Study Start

January 1, 2026

Primary Completion

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

IPD will be shared of patient registration number, Age, Sex, co-morbidities, Pre-op vein mapping data, post-op AVF flow and site at 1, 3 and 6 weeks. Data regarding complications of primary fistula failure, hematoma and infection will be made available.

Time Frame
Made available from 1st july 2027 for 1 year

Locations

PA(1)