Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy

NCT01276392 | Withdrawn

• 1 other identifier: 01-AHTSDKM
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Replacement Disorder

Keywords

regional and systemical anticoagulation; continuous renal replacement therapy; multiplate; rotational thrombelastometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Activation of coagulation

  beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Klinik für Anästhesiologie: lead

Study Sites (1)

Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (6)

• 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.

  PMID: 10850066 BACKGROUND

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

  PMID: 17313917 BACKGROUND

• 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.

  PMID: 9372975 BACKGROUND

• 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.

  PMID: 17069648 BACKGROUND

• 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.

  PMID: 16772739 BACKGROUND

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

  PMID: 16953288 BACKGROUND

Study Officials

• Detlev Kindgen-Milles, Professor,MD

  Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Leiter Interdisziplinäre Operative Intensivstation ZOM-I

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

DE (1)