Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Product safety study for a citrate calcium anticoagulation system: an interventional single-arm open-label trial
Acronym
Study hypothesis
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
To be submitted to the Ethics Committee of Upper Austria, Wagner Jauregg Mental Health Hospital as of 04/02/2009.
Study design
Interventional single-arm open-label trial
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
The following will be assessed at baseline and end of each treatment period: D-Dimer, Mg2+ and sodium concentration
Overall trial start date
01/05/2009
Overall trial end date
31/08/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
14
Participant 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
Recruitment start date
01/05/2009
Recruitment end date
31/08/2009
Locations
Countries of recruitment
Austria
Trial participating centre
Dr.-Karl-Dorrek-Str. 30
Krems
3500
Austria
Sponsor information
Organisation
Danube University Krems (Austria)
Sponsor details
Dr.-Karl-Dorrek-Str. 30
Krems
3500
Austria
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Danube University Krems (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary