Product safety study for a citrate calcium anticoagulation system

ISRCTN ISRCTN04966547
DOI https://doi.org/10.1186/ISRCTN04966547
Secondary identifying numbers N/A
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

Study designInterventional single-arm open-label trial
Primary study designInterventional
Secondary study designOther
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProduct safety study for a citrate calcium anticoagulation system: an interventional single-arm open-label trial
Study objectivesPrimary 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) studiedChronic dialysis
InterventionRegional 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 typeOther
Primary outcome measureThe 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 outcome measuresThe following will be assessed at baseline and end of each treatment period: D-Dimer, Mg2+ and sodium concentration
Overall study start date01/05/2009
Completion date31/08/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants14
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2009
Date of final enrolment31/08/2009

Locations

Countries of recruitment

  • Austria

Study participating centre

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

Sponsor information

Danube University Krems (Austria)
University/education

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

Website http://www.donau-uni.ac.at
ROR logo "ROR" https://ror.org/03ef4a036

Funders

Funder type

University/education

Danube University Krems (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan