Product safety study for a citrate calcium anticoagulation system

ISRCTN	ISRCTN04966547
DOI	https://doi.org/10.1186/ISRCTN04966547
Protocol serial number	N/A
Sponsor	Danube University Krems (Austria)
Funder	Danube University Krems (Austria)

Submission date: 04/02/2009
Registration date: 27/02/2009
Last edited: 27/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dieter Falkenhagen
Scientific

Dr.-Karl-Dorrek-Str. 30
Krems
3500
Austria

Study information

Primary study design	Interventional
Study design	Interventional single-arm open-label trial
Secondary study design	Other
Study type	Participant information sheet
Scientific title	Product safety study for a citrate calcium anticoagulation system: an interventional single-arm open-label trial
Study objectives	Primary goal of the study is the proof of functionality and safety of a algorithm for automated software controlled citrate-calcium anticoagulation. The hypothesis of the authors is that the specification of a target calcium value in the anticoagulated extracorporeal circuit is associated with a high functionality and a high safety using a citrate calcium anticoagulation.
Ethics approval(s)	To be submitted to the Ethics Committee of Upper Austria, Wagner Jauregg Mental Health Hospital as of 04/02/2009.
Health condition(s) or problem(s) studied	Chronic dialysis
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	The following will be assessed at baseline and end of each treatment period: D-Dimer, Mg2+ and sodium concentration
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	14
Key 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
Key exclusion criteria	1. High risk of bleeding, pallets count <40,000/µl 2. Haemoglobin <9 g/dl 3. Alkalosis pH >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
Date of first enrolment	01/05/2009
Date of final enrolment	31/08/2009

Locations

Countries of recruitment

Austria

Study participating centre

Dr.-Karl-Dorrek-Str. 30

Krems
3500
Austria

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes