This randomized, single-center, PROBE trial evaluates whether adding low-dose apixaban (2.5 mg orally every 12 hours) to standard intraluminal heparin lock prolongs primary functional patency of tunneled hemodialysis catheters compared with standard heparin lock alone. Adult patients on hemodialysis with a recently implanted, functioning tunneled catheter (≥8 days) will be randomized 1:1 and followed up to 24 months (or until catheter loss). Primary outcome is time to first intervention for catheter dysfunction or definitive catheter loss. Secondary outcomes include primary-assisted and secondary patency, thrombotic dysfunction, rescue procedures, catheter-related infection, bleeding (ISTH), and mortality. Outcomes adjudication will be blinded.
Age ≥18 years with end-stage kidney disease (CKD stage 5) receiving maintenance hemodialysis or initiating hemodialysis.
Recently placed tunneled, double-lumen central venous hemodialysis catheter (tunneled CVC) in place for ≥8 days, with a post-placement radiograph confirming adequate tip position.
Permitted catheter insertion sites: right internal jugular, left internal jugular, right femoral, or left femoral vein.
Adequate initial catheter function, defined as ability to achieve the prescribed extracorporeal blood flow (suggested ≥300 mL/min) for ≥8 days after catheter placement.
Non-tunneled hemodialysis catheter, subclavian catheter, or intracaval catheter placement not consistent with the protocol (e.g., catheter located in the SVC/IVC without a subcutaneous tunnel, or catheter location/site not permitted by the study).
Tunneled catheter placed <8 days before randomization or radiographically confirmed catheter tip malposition at screening.
Active bleeding; active peptic ulcer disease; or clinically significant gastrointestinal bleeding within the past 30 days; uncorrectable INR >1.5; platelet count <100,000/µL.
High bleeding risk (HAS-BLED score >3) or major bleeding that is active or recent.
Parallel
Apixaban
DrugApixaban 2.5 mg orally every 12 hours, initiated after randomization (TO) and continued until administrative censoring at 24 months or earlier catheter loss/removal/exchange, modality change, kidney transplant, withdrawal, death, or end of study. Temporary interruptions, bleeding events, and adherence are recorded per protocol.
Heparin sodium lock solution
DrugHeparin sodium catheter lock solution (1,000 IU/mL) instilled into each lumen of the tunneled hemodialysis catheter at the end of each dialysis session, using a volume equal to the catheter manufacturer's priming volume per lumen. The same lock protocol is used in both study arms.
Clinically significant catheter dysfunction
Time from randomization to the first clinically significant catheter dysfunction event, defined as either: (1) use of intraluminal thrombolytic therapy (alteplase/rt-PA), or (2) definitive catheter loss (permanent catheter removal or over-the-wire exchange) due to catheter dysfunction. The following are not considered events for the primary outcome: line reversal, flushing with crystalloid, postural changes, or radiography with subsequent manipulation unless they are followed by thrombolytic use or definitive catheter loss.
Minor catheter dysfunction requiring simple maneuvers.
Time from randomization to the first episode of catheter dysfunction managed with simple maneuvers only, defined as any of the following performed to restore adequate dialysis without thrombolytic therapy or catheter exchange: line reversal, flushing/permeabilization with crystalloid, patient repositioning, or radiography followed by catheter manipulation/repositioning. Episodes that subsequently require alteplase/rt-PA or definitive catheter loss are counted as primary outcome events (and are not classified as 'minor').
Rescue procedures for catheter dysfunction (number of procedures per participant)
Total number of protocol-defined rescue procedures performed for catheter dysfunction per participant during follow-up (line reversal, flushing/permeabilization with crystalloid, patient repositioning, or radiography followed by catheter manipulation/repositioning)
Catheter-related infection rate (per 1,000 catheter-days)
Rate of catheter-related infection events defined using CDC criteria, expressed as events per 1,000 catheter-days during follow-up. Catheter-days are calculated from randomization until catheter removal/exchange or censoring.
Major bleeding (ISTH)
Occurrence of major bleeding events defined according to ISTH criteria during follow-up.
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