Product safety study for a citrate calcium anticoagulation system

Product safety study for a citrate calcium anticoagulation system: an interventional single-arm open-label trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN04966547

Enrollment

Registered

2009-02-27

Start date

2009-05-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Chronic dialysis Urological and Genital Diseases

Interventions

Regional anticoagulation with trinatrium citrate and substitution with calcium chloride. Five treatments per patient over 2 weeks, with a duration of 4 hours per treatment planned.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age: 19 to 65 years 2. Chronic dialysis patients 3. Haematocrit (Hkt): 30 bis 45 % 4. Ca2+: 1.0-1.30 mmol/l 5. Weight: >60 kg

Exclusion criteria

Exclusion criteria: 1. High risk of bleeding, pallets count 7.50 4. Acidosis pH <7.35 5. Liver insufficiency 6. Respiratory insufficiency 7. Patients with cardiovascular problems 8. Oral anticoagulans 9. Hepatitis C, B, HIV patients

Design outcomes

Primary

Measure	Time frame
The following will be assessed at baseline, after 15 minutes and then every 60 minutes during treatment (maximum treatment duration is 4 hours): 1. Evaluation of the effectiveness of anticoagulation based on coagulation parameters 2. Time dependency of citrate and calcium values in the extracorporal circuit 3. Anticoagulation state in the extracorporal circuit 4. Citrate and calcium level in the patients blood	—

Measure

Time frame

The following will be assessed at baseline, after 15 minutes and then every 60 minutes during treatment (maximum treatment duration is 4 hours): 1. Evaluation of the effectiveness of anticoagulation based on coagulation parameters 2. Time dependency of citrate and calcium values in the extracorporal circuit 3. Anticoagulation state in the extracorporal circuit 4. Citrate and calcium level in the patients blood

—

Secondary

Measure	Time frame
The following will be assessed at baseline and end of each treatment period: D-Dimer, Mg2+ and sodium concentration	—

Countries

Austria

Outcome results

None listed

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