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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41845

Enrollment

Registered

2016-04-14

Start date

2016-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

bleeding and clotting hemodialysis

Interventions

Regional citrate dialysis with calcium- and magnesium-free citrate dialysis fluid. The dialysis fluid is produced by mixing 9.75 liters of a Ca-, Mg-free, 3,0 mmol/l acetate containing concentrate

calcium-free

citrate

dialysis

magnesium-free

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Stable hemodialysis patients older than 18 years using acenocoumarol, fenprocoumon, acetylsalicylzuur, dipyridamol, clopidrogel, prasugrel or combinations of these.

Exclusion criteria

Exclusion criteria: Inability to give informed consent. Hemodialysis patients who have unstable dialysis sessions i.e. hypotensive periods, muscular cramps or patients who have an increased risk of these afflictions.

Design outcomes

Primary

Measure	Time frame
Primary study objective: Does RCA prevent the increased anticoagulation in the patient as seen with LMWH? Primary outcome: The RCA as proposed prevents a change in TEG in the patient during and after the dialysis session as seen in conventional anticoagulation with LMWH. Due to the small number of observations, hard endpoints like clinical relevant bleeds or the number of blood transfusions will seldom occur. Therefore, these are not used as primary outcome points.	—

Measure

Time frame

Primary study objective: Does RCA prevent the increased anticoagulation in the patient as seen with LMWH? Primary outcome: The RCA as proposed prevents a change in TEG in the patient during and after the dialysis session as seen in conventional anticoagulation with LMWH. Due to the small number of observations, hard endpoints like clinical relevant bleeds or the number of blood transfusions will seldom occur. Therefore, these are not used as primary outcome points.

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Secondary

Measure	Time frame
Secondary study objectives: 1. Does RCA cause an anticoagulation of the extracorporeal system comparable to LMWH? 2. Are serum Ca- and Mg-values after dialysis comparable to those with a conventional anticoagulation with LMWH and a 1.5 and 0.75 mmil/l containing dialysis fluid? The secondary endpoints: 1. During the proposed RCA clotting necessitating termination of the treatment session does not happen more frequently compared to LMWH. The number of signs of clotting in the extracorporeal system is not more frequent in the proposed RCA compared to LMWH. 2. The proposed RCA does not result in a rise in APTT ratio and increase thrombin time in the patient during and after a dialyse session, compared to conservative anticoagulantia with LMWH 3. The serum values of Ca and Mg are similar in both methods.	—

Measure

Time frame

Secondary study objectives: 1. Does RCA cause an anticoagulation of the extracorporeal system comparable to LMWH? 2. Are serum Ca- and Mg-values after dialysis comparable to those with a conventional anticoagulation with LMWH and a 1.5 and 0.75 mmil/l containing dialysis fluid? The secondary endpoints: 1. During the proposed RCA clotting necessitating termination of the treatment session does not happen more frequently compared to LMWH. The number of signs of clotting in the extracorporeal system is not more frequent in the proposed RCA compared to LMWH. 2. The proposed RCA does not result in a rise in APTT ratio and increase thrombin time in the patient during and after a dialyse session, compared to conservative anticoagulantia with LMWH 3. The serum values of Ca and Mg are similar in both methods.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)