A pilot study for performing hemodialysis without heparin using a citrate-containing dialysis fluid. Can the increased bleeding tests of the patient be prevented?

A pilot study regarding regional anticoagulation by a citrate containing dialysis fluid

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38196008

Enrollment

Registered

2021-07-01

Start date

2017-07-01

Completion date

Unknown

Last updated

2021-09-13

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

Conditions

Regional anticoagulation in chronic hemodialysis patients with a moderately increased risk of bleeding Circulatory System

Interventions

Each patient will function as its own control and will be treated with both LMWH and citrate-HD. Each patient will be treated with two consecutive citrate dialyses (C1 and C2). These dialyses will be

35 ml/hour. LMWH (dalteparin)-HD is the usual standard HD The treatment lasted for the time of the hemodialysis session being 3.5 to 4.25 hours. The same for both arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hemodialysis patients 2. Older than 18 years 3. Cardiovascular stable during and after their hemodialysis sessions 4. Taking acenocoumarol, fenprocoumon, acetylsalicylic acid, dipyridamol, clopidogrel, prasugrel or a combination here of 5. Good functioning arteriovenous shunt or fistula (blood flow >450 ml/min) for dialysing with two needles or double lumen hemodialysis catheter (blood flow >250ml/min)

Exclusion criteria

Exclusion criteria: 1. Unable to give informed consent 2. Unstable during hemodialysis i.e. Drop of blood pressure, muscular cramps 3. With an increased risk of being unstable during hemodialysis 4. With predialysis an ionized calcium 0.5 mmol/l during the study 7. With an increase of erythropoietin dosage >25% during the study 8. With a dysfunctioning arteriovenous shunt or fistula or hemodialysis catheter (see inclusion criteria) 9. With a coagulation defect not to be attributed to the used medication

Design outcomes

Primary

Measure	Time frame
(Anti)coagulation is measured before, halfway en after the hemodialysis session with non-activated tromboelastometry (NATEM) in whole blood (ROTEM Delta, Tem-innovations München), APTT (Sysmex CS-5100 System, Siemens Healthineers), ionized Ca (ABL90 FLEX, Radiometer).	—

Secondary

Measure	Time frame
1. Clotting phenomena in venous air trap and dialyzer are graded by visual inspection after HD. Venous air trap: 1: no clotting; 2: rim; 3: clot. Clotting phenomena in the dialyzer: 0: no clotted fibers, 1: 50% of fibers clotted. Grading is done by a panel of 3 nephrologists and nurses, who are blinded to the method used. Grades are averaged 2. Ionized Ca (ABL90 FLEX, Radiometer), Ca and Mg (Dimension VISTA 1500, Siemens Healthineers), are measured before, halfway en after the hemodialysis session	—

Measure

Time frame

1. Clotting phenomena in venous air trap and dialyzer are graded by visual inspection after HD. Venous air trap: 1: no clotting; 2: rim; 3: clot. Clotting phenomena in the dialyzer: 0: no clotted fibers, 1: 50% of fibers clotted. Grading is done by a panel of 3 nephrologists and nurses, who are blinded to the method used. Grades are averaged 2. Ionized Ca (ABL90 FLEX, Radiometer), Ca and Mg (Dimension VISTA 1500, Siemens Healthineers), are measured before, halfway en after the hemodialysis session

—

Countries

Netherlands

Outcome results

None listed

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