Apixaban to help arm fistulas mature in people with end-stage kidney disease
"Effect of Perioperative and Short-Term Apixaban Therapy on Arteriovenous Fistula Maturation in Patients With End-Stage Renal Disease: A Randomized Controlled Trial"
This trial will try a short course of apixaban in adults with end-stage kidney disease getting a new arm arteriovenous fistula to see if it helps the fistula mature for hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Combined military hospital lahore Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07559942 on ClinicalTrials.gov |
What this trial studies
This interventional study gives perioperative and short-term apixaban around the time of primary upper-extremity arteriovenous fistula creation to reduce microthrombotic events during the critical 4–6 week maturation period. Eligible adults have end-stage renal disease (eGFR <15 mL/min/1.73 m2 or on dialysis) and suitable vessels on preoperative duplex ultrasound. Key exclusions include therapeutic anticoagulation, dual antiplatelet therapy, bleeding diathesis, prior intracranial hemorrhage, or apixaban hypersensitivity. The main outcomes are fistula maturation rates and safety, particularly bleeding complications, with all procedures and follow-up at the enrolling hospital.
Who should consider this trial
Good fit: Adults (≥18) with end-stage kidney disease who plan a primary upper-extremity AVF and have suitable artery and vein sizes on preoperative ultrasound and can provide informed consent are ideal candidates.
Not a fit: Patients already on therapeutic anticoagulation, on dual antiplatelet therapy, with known bleeding diatheses or prior intracranial hemorrhage, or with apixaban allergy are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, short-term apixaban could increase the proportion of fistulas that mature, reducing catheter dependence and repeat procedures.
How similar studies have performed: There are no randomized trials specifically testing short-term perioperative apixaban for AVF maturation, so this approach is relatively novel in this precise setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Lahore, Punjab Province
- Combined Military Hospital, Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Muhammad Kashif, FCPS Surgery
- Email: kashiramzan@gmail.com
- Phone: 00923219698888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.