Efficacy of 5% Trisodium Citrate and Low Dose Heparin as Catheter-Locking Solution for Central Venous Hemodialysis Catheters: A Randomized Controlled Study

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20231106002

Enrollment

216

Registered

2023-11-06

Start date

2023-06-25

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Central venous catheter dysfunction (CVC dysfunction) is failure to maintain the prescribed extracorporeal blood flow required for adequate hemodialysis without lengthening the prescribed HD treatment. A catheter locking anticoagulant (CLA) by trisodium citrate (TSC) or unfractionated heparin (UFH) is recommended in real practice to prevent this problem. Central venous catheter dysfunction, CVC dysfunction, Catheter locking anticoagulant, CLA, Trisodium citrate, TSC, Unfractionated heparin, UFH

Interventions

1. Prepared of using 5 mL of 30% TSC, then added 25 mL of 0.9% sodium chloride (NSS) for 5% TSC. 2. After completing every HD treatment, each lumen of the catheter was flushed with 10 mL of NSS, and t

Active Comparator Drug,Active Comparator Drug

5% trisodium citrate (TSC),1000 unit/ml of unfractionated heparin

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Hemodialysis patients, 2. Well-positioned of non-tunnel cuffed catheter (NTCC) or tunnel cuffed catheter (TCC) expected to be needed for more than 1 week without flow problems (a persistent inability to obtain blood flow rate [BFR] above 250 mL/minute)

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic diathesis conditions (liver failure, disseminated intravascular coagulopathy, leukemia, vitamin K deficiency, hemophilia, or thrombocytopenia), 2. Hypercoagulable states (deep vein thrombosis, pulmonary embolism, or antiphospholipid syndrome), 3. Hematologic diseases (paroxysmal nocturnal hemoglobinuria, myeloproliferative neoplasms, polycythemia vera, essential thrombocytosis, or hemolytic anemia), 4. Metastatic cancer, 5. Currently using of oral contraceptive pills, 6. Currently using one of the following anticoagulants: warfarin, UFH, enoxaparin, rivaroxaban, apixaban, or dabigatran, 7. Proven or suspected heparin induced thrombocytopenia, 8. Allergic to UFH or TSC, 9. Pregnant, 10. Unable to obtain crucial data, 11. Refused to participate

Design outcomes

Primary

Measure	Time frame
Rate of Catheter dysfunction (CD) At 3 months after end of the intervention Percentage	—

Secondary

Measure	Time frame
Rates of catheter related blood stream infection(CRBSI) At 3 months after end of the intervention Percentage,Exit site infection (ESI) At 3 months after end of the intervention Percentage,Bleeding episodes At 3 months after end of the intervention Events	—

Countries

Thailand

Contacts

Public ContactKwansuphang Wongwatanasanti

Thammasat university

kwansuphang@gmail.com0626429195

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026