Product safety study for a citrate calcium anticoagulation system
ISRCTN | ISRCTN04966547 |
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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
Scientific
Dr.-Karl-Dorrek-Str. 30
Krems
3500
Austria
Study information
Study design | Interventional single-arm open-label trial |
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Primary study design | Interventional |
Secondary study design | Other |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/05/2009 |
Completion date | 31/08/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
3500
Austria
Sponsor information
Danube University Krems (Austria)
University/education
University/education
Dr.-Karl-Dorrek-Str. 30
Krems
3500
Austria
Website | http://www.donau-uni.ac.at |
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https://ror.org/03ef4a036 |
Funders
Funder type
University/education
Danube University Krems (Austria)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |