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Effectiveness of Dual-Citrate Versus Single-Citrate Anticoagulation in Patients at High Bleeding Risk Undergoing Hemodiafiltration: A Randomized Controlled Trial

Effectiveness of Dual-Citrate Versus Single-Citrate Anticoagulation in Patients at High Bleeding Risk Undergoing Hemodiafiltration: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106061
Enrollment
Unknown
Registered
2025-07-16
Start date
2025-07-27
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease

Interventions

Control Group:Single-Phase Citrate Anticoagulation
Intervention Group:Two-Segment Citrate Anticoagulation

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age: Patients aged =18 years. 2. Indication: With an indication for IHD (Intermittent Hemodialysis). 3. Vascular Access: Well-functioning vascular access required. If using a central venous catheter (CVC) for dialysis: must be connected in the normal direction. Palindrome™ catheter (due to its symmetric design): May be connected in normal or reversed direction (minimal recirculation). 4. High Bleeding Risk (meeting =1 of the following): a. Active bleeding (e.g., hemoptysis, gastrointestinal bleeding, cerebral hemorrhage). b. Coagulopathy: PT or APTT above the upper limit of normal (ULN); OR Platelet count below the lower limit of normal (LLN). c. Peri-procedural period: Within 1 day before surgery/invasive procedure; AND within 7 days after surgery/invasive procedure.

Exclusion criteria

Exclusion criteria: 1. Severe Hepatic Impairment (Total bilirubin (TBIL) =60 µmol/L); 2. Refractory Shock Persistent hypotension (SBP 3 mmol/L 5. Severe Hypocalcemia, Serum total calcium <1.8 mmol/L 6. Concurrent Clinical Trial Participation 7. Currently enrolled in another interventional clinical study Contraindication to High-Flux Dialyzer Not suitable for polyarylethersulfone (PAES) high-flux membrane dialyzers 8. Contraindication to Low-Potassium Dialysate Pre-dialysis hypokalemia (serum K? <3.5 mmol/L) 9. Exclusion applies to protocols using low-potassium dialysate Recent Anticoagulant/Thrombolytic Use: Within 24 hours: Heparin, LMWH, argatroban, nafamostat mesilate, gabexate mesilate, bivalirudin, urokinase, alteplase Within 5 days: Warfarin, danaparoid, fondaparinux, rivaroxaban, dabigatran etexilate, apixaban, edoxaban

Design outcomes

Primary

MeasureTime frame
Early circuit termination or filter replacement due to extracorporeal circuit clotting;

Secondary

MeasureTime frame
Premature Circuit Termination or Filter Replacement Due to Any Cause;First Filter Lifespan;Initial Filter Clotting Severity Score;Clot Burden in Venous Chamber at Discontinuation of the First Circuit;Severe Complications Associated with Citrate Anticoagulation;Whether to adjust the citrate infusion rate based on blood gas analysis results;Whether to administer intravenous calcium gluconate based on blood gas analysis results;

Countries

China

Contacts

Public ContactXu Damin

Peking University First Hospital

xdmcmu@163.com+86 159 0124 1994

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026