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Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy

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ClinicalTrials.gov Identifier: NCT01276392
Recruitment Status : Withdrawn (A main person involved left the site)
First Posted : January 13, 2011
Last Update Posted : August 20, 2015
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:
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.

Condition or disease
Kidney Replacement Disorder

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Function, Whole Blood Coagulation and Fibrinolysis During Continuous Renal Replacement Therapy - a Comparison of Citrate and Heparin Anticoagulation
Study Start Date : January 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

10 Patients undergoing continuous renal replacement therapy using heparin for providing anticoagulation. Blood samples taken at 8 predefined timepoints.
10 Patients undergoing continuous renal replacement therapy using citrate for providing anticoagulation. Blood samples taken at 8 predefined timepoints.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Activation of coagulation [ Time Frame: beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis ]
    blood samples for multiplate, rotem and systemic coagulation paramters

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critical ill patients with acute renal failure and the need of continuous renal replacement therapy.

Inclusion Criteria:

  • Age > 18 years, acute renal failure with need for continuous veno-venous renal replacement therapy

Exclusion Criteria:

  • Age < 18 years, pregnancy, contraindications for one of the two anticoagulation methods, missing informed consent or disagreement in the progress of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276392

Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Klinik für Anästhesiologie
Principal Investigator: Detlev Kindgen-Milles, Professor,MD Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University

Responsible Party: Klinik für Anästhesiologie, Leiter Interdisziplinäre Operative Intensivstation ZOM-I, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01276392     History of Changes
Other Study ID Numbers: 01-AHTSDKM
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf:
regional and systemical anticoagulation
continuous renal replacement therapy
rotational thrombelastometry

Additional relevant MeSH terms:
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action