Condition category
Urological and Genital Diseases
Date applied
04/02/2009
Date assigned
27/02/2009
Last edited
27/02/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dieter Falkenhagen

ORCID ID

Contact details

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

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

http://www.donau-uni.ac.at

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

Publication citations

Additional files

Editorial Notes