Clinical trial NCT01276392: Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy
Official title: Platelet Function, Whole Blood Coagulation and Fibrinolysis During Continuous Renal Replacement Therapy - a Comparison of Citrate and Heparin Anticoagulation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Kidney Replacement Disorder
Keywords: regional and systemical anticoagulation
continuous renal replacement therapy
multiplate
rotational thrombelastometry
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical ill patients with acute renal failure and the need of continuous renal replacement therapy.

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.


Eligibility 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

Primary outcomes:
measure: Filter life time of continuous renal replacement therapy
timeFrame: Individual time point, standardized
Secondary outcomes:
measure: Activation of coagulation
timeFrame: beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf
state: NRW
Study officials:
affiliation: Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University
name: Detlev Kindgen-Milles, Professor,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Toft P, Gilsaa T. [Acute renal failure in critically ill patients]. Ugeskr Laeger. 2007 Feb 19;169(8):692-5. Danish.
citation: Davenport 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.
citation: Bouman 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.
citation: Sabovic 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.
citation: Lang T, von Depka M. [Possibilities and limitations of thrombelastometry/-graphy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S20-9. German.