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Clinical Study on the Priming Method for Extracorporeal Circulation in Hemoperfusion Combined with Hemodialysis in Series

Clinical Study on the Priming Method for Extracorporeal Circulation in Hemoperfusion Combined with Hemodialysis in Series

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125678
Enrollment
Unknown
Registered
2026-05-29
Start date
2024-11-27
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

End-Stage Renal Disease

Interventions

The traditional priming group:Traditional priming method:Following standard guidelines, the HA130 cartridge and Fx10 filter were primed separately. The procedure was as follows: 1.Cartridge priming:
the cartridge underwent a dynamic heparinization process involving a 100 mL/min slow flush with 2500 mL of heparinized saline (containing 6,250 U of heparin), followed by a 50 mL/min slow flush with 5
2.Filter priming:the cartridge side was clamped
the filter was primed according to the TSHNA 0006-2023 standard, which involved flushing the blood compartment with 800 mL of normal saline to remove air
3.Final circuit reparation:the dialysate lines were connected to rinse the dialysate compartment and remove external air, followed by a 10-minute closed-loop recirculation with 200 mL of normal saline
The modified priming group:The Second modified priming as follows: 1. The slow-prime phase (a fixed volume of 500 mL of heparinized saline) was delivered at the designated variable flow rate 100 mL/m
2. The fast-flush phase (the designated variable volume of 2000 mL of saline) was delivered at the fixed flow rate of 250 mL/min
3. Rinsing of the dialysate compartment, followed by a final 10-minute closed-loop recirculation with 200 mL of normal saline to complete the process.

Sponsors

The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) age 18–80 years; (2) receiving stable HAHD therapy (once every two weeks) for at least 3 months; (3) adequate vascular access function with a blood flow >=200 mL/min.

Exclusion criteria

Exclusion criteria: (1) known hypersensitivity or intolerance to dialyzer or hemoadsorption cartridge materials; (2) acute severe infections (defined as uncontrolled systemic sepsis, bacteremia, or active infections causing hemodynamic instability); (3) severe comorbidities (e.g., cardiopulmonary insufficiency, cerebrovascular disease, malignant tumors); (4) high bleeding risk (e.g., bleeding tendency, active bleeding, or platelet count < 50×10^9/L).

Design outcomes

Primary

MeasureTime frame
Blood coagulation during cardiopulmonary bypass;Purity of Priming fluid;

Secondary

MeasureTime frame
Solute Clearance Efficacy;Priming Time;Saline volume of Priming;Heparin volume of Priming;

Countries

China

Contacts

Public ContactJing Chen/Bin Dai

The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)

chenjzrx@163.com+86 21 8188 5388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026