Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy

Kidney Replacement Disorder Clinical Trial

Official title:

Platelet Function, Whole Blood Coagulation and Fibrinolysis During Continuous Renal Replacement Therapy - a Comparison of Citrate and Heparin Anticoagulation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01276392
• Other study ID #: 01-AHTSDKM
• Status: Withdrawn
• Phase: N/A
• First received: January 12, 2011
• Last updated: August 19, 2015
• Start date: January 2011
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Replacement Disorder

Locations

Country	Name	City	State
Germany	Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Anästhesiologie

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. Review. — View Citation

Lang T, von Depka M. [Possibilities and limitations of thrombelastometry/-graphy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S20-9. German. — View 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. — View 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. Review. German. — View Citation

Toft P, Gilsaa T. [Acute renal failure in critically ill patients]. Ugeskr Laeger. 2007 Feb 19;169(8):692-5. Danish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Individual time point, standardized	Yes
Secondary	Activation of coagulation	blood samples for multiplate, rotem and systemic coagulation paramters	beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis	No