What is the management for a patient on Xarelto (rivaroxaban) due to a blood clot, who now presents with hematuria?

Management of Hematuria in a Patient on Xarelto (Rivaroxaban)

Immediately stop Xarelto and assess the severity of bleeding to determine if this represents major bleeding requiring reversal therapy or minor bleeding that can be managed conservatively. 1

Initial Assessment and Immediate Actions

Stop rivaroxaban immediately and implement the following measures 1, 2:

• Assess bleeding severity using ACC criteria: major bleeding is defined by bleeding in a critical site (including urinary tract with hemodynamic compromise), hemodynamic instability, or hemoglobin drop ≥2 g/dL or need for ≥2 units RBC transfusion 1, 2
• Suspend all concomitant antiplatelet agents (aspirin, clopidogrel, etc.) 1, 2
• Provide hemodynamic support and volume resuscitation as needed 1, 2
• Check hemoglobin/hematocrit to assess for ongoing blood loss 2
• Evaluate renal function - rivaroxaban is renally cleared and accumulates in renal impairment, with half-life extending to 17 hours in elderly or renally impaired patients 3

Reversal Strategy Based on Bleeding Severity

For Major or Life-Threatening Hematuria:

• Administer andexanet alfa (specific reversal agent for rivaroxaban) 1, 3:

  • High-dose regimen: 800 mg IV bolus at 30 mg/min, followed by 8 mg/min infusion for up to 120 minutes (960 mg total) if last dose of rivaroxaban >10 mg was taken <8 hours prior or timing unknown 1
  • Low-dose regimen: 400 mg IV bolus followed by 4 mg/min infusion for up to 120 minutes (480 mg total) if last dose ≤10 mg was taken <8 hours prior, or any dose taken ≥8 hours prior 1

• If andexanet alfa is unavailable, administer four-factor prothrombin complex concentrate (4F-PCC) or activated PCC 1, 3

• Consider activated charcoal if rivaroxaban was ingested within 2-4 hours 1

For Minor to Moderate Hematuria:

• Hold rivaroxaban for 1-2 days - most cases of anticoagulant-related hematuria resolve with brief interruption 4
• Encourage oral hydration with clear fluids 4, 5
• Monitor hemoglobin serially to ensure stability 2, 4

Urological Evaluation

All patients with hematuria on anticoagulation require urological assessment to rule out malignancy, regardless of anticoagulation status 4, 6, 5:

• The positive predictive value for urological malignancy in men >60 years with macroscopic hematuria is 22.1%, and 8.3% in women of the same age 5
• Baseline investigations should include: full blood count, urea and electrolytes, urinalysis with microscopy, culture and sensitivities 5
• Urgent urological referral (within 2 weeks) should be arranged for outpatient cystoscopy and upper tract imaging 5
• The risk of urological malignancy is lower but not zero when INR is elevated or patient is anticoagulated 6

Indications for Hospital Admission

Admit the patient if any of the following are present 5:

• Clot retention or inability to void
• Hemodynamic instability
• Uncontrolled pain
• Signs of sepsis/infection
• Acute kidney injury (rivaroxaban can cause anticoagulant-related nephropathy with hematuria and AKI) 7
• Severe comorbidities
• Heavy ongoing hematuria despite holding anticoagulation
• Social factors preventing safe home management

Restarting Anticoagulation

Timing of anticoagulation restart depends on thrombotic risk versus bleeding risk 2:

• Delay restart if: bleeding occurred in critical site, high risk of rebleeding, source not definitively treated, or further procedures planned 2
• Restart within 7 days if: high thrombotic risk (atrial fibrillation with CHA₂DS₂-VASc ≥2, recent VTE) and bleeding controlled 2
• Consider switching to LMWH rather than restarting rivaroxaban if recurrent hematuria is a concern 4

Critical Pitfalls to Avoid

• Do not rely on PT/aPTT to assess rivaroxaban effect - normal values do not exclude therapeutic or supratherapeutic levels; prolonged PT suggests clinically important levels 8
• Rivaroxaban is not dialyzable due to high plasma protein binding 3
• Do not routinely catheterize - urinary catheterization does not reduce rebleeding rates and may worsen hematuria 4
• Do not restrict patient mobility - activity level does not affect rebleeding rates 4
• Antiplatelet therapy can be continued in mild cases as it does not significantly increase rebleeding risk 4