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Regional citric acid anticoagulation for reducing the bleeding risk in maintenance hemodialysis patients at high risk of bleeding: Multicenter, randomized, positive-controlled, open-label clinical study

Regional citric acid anticoagulation for reducing the bleeding risk in maintenance hemodialysis patients at high risk of bleeding: Multicenter, randomized, positive-controlled, open-label clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094057
Enrollment
Unknown
Registered
2024-12-16
Start date
2024-12-27
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

chronic kidney disease

Interventions

Regional Citrate Anticoagulation Therapy Group:Sodium Citrate Solution for Anticoagulation, 200ml: 8g per bag
Low Molecular Weight Heparin Anticoagulation Control Group:Low Molecular Weight Heparin Sodium Injection, 0.6ml: 6000 IU

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18 to 75 years old, with no restrictions on gender or ethnicity; 2) Diagnosed with chronic kidney disease stage 5, undergoing regular hemodialysis, 2-3 times per week, for more than 3 months; 3) Concomitant use of anticoagulants (warfarin, NOACs) and/or antiplatelet drugs (aspirin, glycoprotein IIb/IIIa inhibitors, etc.); 4) Signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Individuals allergic to anticoagulant drugs such as citric acid or heparin and its analogs; 2) Contraindications to anticoagulant drugs, such as coagulation disorders, active bleeding, heparin-induced thrombocytopenia, severe hypoxemia, hyperlactemia, severe hypocalcemia, metabolic alkalosis, and intractable hypernatremia; 3) Life expectancy of less than 3 months; 4) Severe cardiac, hepatic, or respiratory dysfunction, patients with malignant tumors; 5) Unable or unwilling to sign an informed consent form; 6) Participation in other clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frame
The incidence of major bleeding events;

Secondary

MeasureTime frame
The incidence rate of non-major bleeding events;Anticoagulation effects;Dialysis Adequacy;side effects;

Countries

China

Contacts

Public ContactWang Xiaohua

The Seventh Affiliated Hospital of Sun Yat-sen University

wangxiaohua@sysush.com+86 755 81206802

Outcome results

None listed

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