Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Replacement Disorder

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Duesseldorf, NRW, Germany, 40225
      • Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critical ill patients with acute renal failure and the need of continuous renal replacement therapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Klinik für Anästhesiologie
• Investigators: Principal Investigator: Detlev Kindgen-Milles, Professor,MD, Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University

Publications and helpful links

General 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.
• Toft P, Gilsaa T. [Acute renal failure in critically ill patients]. Ugeskr Laeger. 2007 Feb 19;169(8):692-5. Danish.
• 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.
• 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.
• 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.
• Lang T, von Depka M. [Possibilities and limitations of thrombelastometry/-graphy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S20-9. German.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: multiplate; continuous renal replacement therapy; rotational thrombelastometry; regional and systemical anticoagulation
• Other Study ID Numbers: 01-AHTSDKM