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

Not Applicable

Completed

• Conditions: Regional anticoagulation in chronic hemodialysis patients with a moderately increased risk of bleeding; Circulatory System

• Registration Number: ISRCTN38196008
• Lead Sponsor: Albert Schweitzer Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-29
• Study Start: 2021-07-01
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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 <1.0 mmol/l
5. With changes in their dialysis protocol during the study i.e. Change of type and/or size of dialyzer, or change in blood- and/or dialysis fluid flow or change of dialysis modality (hemodialysis, hemofiltration, hemodiafiltration) or change in ultrafiltration
6. With a decrease in Hb >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(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 Outcome Measures

Name	Time	Method
<br> 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.<br> Clotting phenomena in the dialyzer: 0: no clotted fibers, 1: <10% of fibers clotted, 2: 10%-50% of fibers clotted, 3: >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<br> 2. Ionized Ca (ABL90 FLEX, Radiometer), Ca and Mg (Dimension VISTA 1500, Siemens Healthineers), are measured before, halfway en after the hemodialysis session<br>