Effect of Apiban Therapy on AVF Maturation in ESRD Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCombined military hospital lahore

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Known bleeding diathesis or hypercoagulable state.

Current therapeutic anticoagulation (any indication).

Current dual antiplatelet therapy.

History of intracranial hemorrhage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apixaban

    Drug

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

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Apiban groupExperimental treatment 1 intervention
Group B: Non-Apiban groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

AV Fistula Maturation

As per standard definitions

Time frame
Six weeks from index operation

Secondary outcomes

Other outcomes

Sponsors and contacts

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