Kidney Replacement DisorderNCT01276392
Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy
An observational study of Kidney Replacement Disorder, run by Klinik für Anästhesiologie at 1 site in Germany.
Trial summary
Actual clinical practice predominantly makes use of heparin (systemically) or citrate regionally as anticoagulation in the extracorporeal circulation for renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Replacement Disorder
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical ill patients with acute renal failure and the need of continuous renal replacement therapy.
Who may be able to join
- Age > 18 years, acute renal failure with need for continuous veno-venous renal replacement therapy
Who cannot join
- Age < 18 years, pregnancy, contraindications for one of the two anticoagulation methods, missing informed consent or disagreement in the progress of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Platelet Function, Whole Blood Coagulation and Fibrinolysis During Continuous Renal Replacement Therapy - a Comparison of Citrate and Heparin Anticoagulation
Actual clinical practice predominantly makes use of heparin (systemically) or citrate regionally as anticoagulation in the extracorporeal circulation for renal replacement therapy. We aim to find out if different anticoagulation strategies may lead to different levels of platelet activation and whole blood coagulation. Regarding coagulation activation, it remains uncertain if there is an advantage for one of these methods. However, it is of major interest to minimize the risk of any additional clotting activation via extracorporeal circulation in these usually critically ill patients.
- Conditions
- Kidney Replacement Disorder
- Keywords
- regional and systemical anticoagulation, continuous renal replacement therapy, multiplate, rotational thrombelastometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heparin | 10 Patients undergoing continuous renal replacement therapy using heparin for providing anticoagulation. Blood samples taken at 8 predefined timepoints. | |
| CiCa | 10 Patients undergoing continuous renal replacement therapy using citrate for providing anticoagulation. Blood samples taken at 8 predefined timepoints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter life time of continuous renal replacement therapy
Filter life time measured in hours of duration of continuos renal replacement therapy, filter life time end, when system clotts.
Measured: Individual time point, standardized
Secondary outcomes (1)
Activation of coagulation
blood samples for multiplate, rotem and systemic coagulation paramters
Measured: beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2014 (estimated)
- Study completionFeb 2015 (estimated)
Why it stopped: A main person involved left the site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney Replacement DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Anästhesiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Detlev Kindgen-Milles, Professor,MD, Principal investigator, Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276392
- Sponsor's protocol ID
- 01-AHTSDKM
- Status last verified
- Aug 2015
- First submitted
- 12 Jan 2011
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schaefer RM, Barenbrock M, Teschner M, Bahner U. [Extracorporeal renal replacement therapies in acute renal failure]. Med Klin (Munich). 2000 May 15;95(5):273-8. doi: 10.1007/pl00002121. German.
PubMed 10850066Toft P, Gilsaa T. [Acute renal failure in critically ill patients]. Ugeskr Laeger. 2007 Feb 19;169(8):692-5. Danish.
PubMed 17313917Davenport A. The coagulation system in the critically ill patient with acute renal failure and the effect of an extracorporeal circuit. Am J Kidney Dis. 1997 Nov;30(5 Suppl 4):S20-7. doi: 10.1016/s0272-6386(97)90538-2.
PubMed 9372975Bouman CS, de Pont AC, Meijers JC, Bakhtiari K, Roem D, Zeerleder S, Wolbink G, Korevaar JC, Levi M, de Jonge E. The effects of continuous venovenous hemofiltration on coagulation activation. Crit Care. 2006;10(5):R150. doi: 10.1186/cc5080.
PubMed 17069648Sabovic M, Salobir B, Preloznik Zupan I, Bratina P, Bojec V, Buturovic Ponikvar J. The influence of the haemodialysis procedure on platelets, coagulation and fibrinolysis. Pathophysiol Haemost Thromb. 2005;34(6):274-8. doi: 10.1159/000093107.
PubMed 16772739Lang T, von Depka M. [Possibilities and limitations of thrombelastometry/-graphy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S20-9. German.
PubMed 16953288
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function, Whole Blood Coagulation and Fibrinolysis During Continuous Renal Replacement Therapy - a Comparison of Citrate and Heparin Anticoagulation
- ClinicalTrials.gov ID
- NCT01276392
- Acronym / sponsor ID
- 01-AHTSDKM
- Conditions
- Kidney Replacement Disorder
- Keywords
- regional and systemical anticoagulation, continuous renal replacement therapy, multiplate, rotational thrombelastometry
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: A main person involved left the site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Klinik für AnästhesiologieUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Actual clinical practice predominantly makes use of heparin (systemically) or citrate regionally as anticoagulation in the extracorporeal circulation for renal replacement therapy. We aim to find out if different anticoagulation strategies may lead to different levels of platelet activation and whole blood coagulation. Regarding coagulation activation, it remains uncertain if there is an advantage for one of these methods. However, it is of major interest to minimize the risk of any additional clotting activation via extracorporeal circulation in these usually critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin | – | –10 Patients undergoing continuous renal replacement therapy using heparin for providing anticoagulation. Blood samples taken at 8 predefined timepoints. |
| CiCa | – | –10 Patients undergoing continuous renal replacement therapy using citrate for providing anticoagulation. Blood samples taken at 8 predefined timepoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical ill patients with acute renal failure and the need of continuous renal replacement therapy.
Key inclusion criteria (1 listed)
- Age > 18 years, acute renal failure with need for continuous veno-venous renal replacement therapy
Key exclusion criteria (1 listed)
- Age < 18 years, pregnancy, contraindications for one of the two anticoagulation methods, missing informed consent or disagreement in the progress of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Filter life time of continuous renal replacement therapy
Time frame: Individual time point, standardized
Filter life time measured in hours of duration of continuos renal replacement therapy, filter life time end, when system clotts.
1 secondary outcome
Activation of coagulation
Time frame: beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Background: PubMed 10850066Schaefer RM, Barenbrock M, Teschner M, Bahner U. [Extracorporeal renal replacement therapies in acute renal failure]. Med Klin (Munich). 2000 May 15;95(5):273-8. doi: 10.1007/pl00002121. German.
- Background: PubMed 17313917Toft P, Gilsaa T. [Acute renal failure in critically ill patients]. Ugeskr Laeger. 2007 Feb 19;169(8):692-5. Danish.
- Background: PubMed 9372975Davenport A. The coagulation system in the critically ill patient with acute renal failure and the effect of an extracorporeal circuit. Am J Kidney Dis. 1997 Nov;30(5 Suppl 4):S20-7. doi: 10.1016/s0272-6386(97)90538-2.
- Background: PubMed 17069648Bouman CS, de Pont AC, Meijers JC, Bakhtiari K, Roem D, Zeerleder S, Wolbink G, Korevaar JC, Levi M, de Jonge E. The effects of continuous venovenous hemofiltration on coagulation activation. Crit Care. 2006;10(5):R150. doi: 10.1186/cc5080.
- Background: PubMed 16772739Sabovic M, Salobir B, Preloznik Zupan I, Bratina P, Bojec V, Buturovic Ponikvar J. The influence of the haemodialysis procedure on platelets, coagulation and fibrinolysis. Pathophysiol Haemost Thromb. 2005;34(6):274-8. doi: 10.1159/000093107.
- Background: PubMed 16953288Lang T, von Depka M. [Possibilities and limitations of thrombelastometry/-graphy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S20-9. German.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Detlev Kindgen-Milles, Professor,MD principal investigator
Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Replacement Disorder, run by Klinik für Anästhesiologie at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter life time of continuous renal replacement therapy (time frame: Individual time point, standardized). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01276392, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.