Text Size

Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy

This study is currently recruiting participants.
Verified March 2012 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01276392
First received: January 12, 2011
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Kidney Replacement Disorder

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Filter life time of continuous renal replacement therapy [ Time Frame: Individual time point, standardized ] [ Designated as safety issue: Yes ]
    Filter life time measured in hours of duration of continuos renal replacement therapy, filter life time end, when system clotts.


Secondary Outcome Measures:
  • Activation of coagulation [ Time Frame: beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis ] [ Designated as safety issue: No ]
    blood samples for multiplate, rotem and systemic coagulation paramters


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276392

Contacts
Contact: Timur N Sellmann, MD (+)49-211-81 ext 18101 timur.sellmann@med.uni-duesseldorf.de
Contact: Robert Kalb, MD (+)49-211-81 ext 18101 robert.kalb@med.uni-duesseldorf.de

Locations
Germany
Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Timur N Sellmann, MD     (+49)211-81 ext 18101     timur.sellmann@med.uni-duesseldorf.de    
Contact: Robert Kalb, MD     (+49)211-81 ext 18101     robert.kalb@med.uni-duesseldorf.de    
Sub-Investigator: Timur N Sellmann, MD            
Sub-Investigator: Robert Kalb, MD            
Principal Investigator: Detlev Kindgen-Milles, Professor,MD            
Sponsors and Collaborators
Klinik für Anästhesiologie
Investigators
Principal Investigator: Detlev Kindgen-Milles, Professor,MD Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University
  More Information

Publications:

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
Study First Received: January 12, 2011
Last Updated: March 15, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013