RecruitingNot ApplicableNCT07559942

Effect of Apiban Therapy on AVF Maturation in ESRD Patients

"Effect of Perioperative and Short-Term Apixaban Therapy on Arteriovenous Fistula Maturation in Patients With End-Stage Renal Disease: A Randomized Controlled Trial"


Sponsor

Combined military hospital lahore

Enrollment

190 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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 \[9\].


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria1

  • 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.

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Interventions

DRUGApixaban

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


Locations(1)

Combined Military Hospital, Lahore

Lahore, Punjab Province, Pakistan

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NCT07559942


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