Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration - Full Text View

Purpose

The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.

Aim of the present study is to determine

whether nadroparin accumulates in plasma
whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
the effects of nadroparin during critical illness on coagulation and anticoagulation

Condition	Intervention	Phase
Kidney Acute Renal Failure Multiple Organ Failure	Procedure: CVVH 4 to 2 L/h Procedure: CVVH 2 to 4L/h	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

U.S. FDA Resources

Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:

Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	February 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: hemofiltration at 4L/h Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration	Procedure: CVVH 4 to 2 L/h CVVH is initiated at 4L/h and is converted to 2L/h after 60 min Other Name: continuous venovenous hemofiltration
Active Comparator: hemofiltration at 2L/h hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min	Procedure: CVVH 2 to 4L/h CVVH is initiated at 2L/h and is converted to 4L/h after 60 min Other Name: continous venovenous hemofiltration

Detailed Description:

The low molecular weight heparin (LMWH) nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. LMWH accumulate in patients with chronic renal failure. Continuous venovenous hemofiltration (CVVH) is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. If not, accumulation is expected and the risk of bleeding for the patient increases. Because critically ill patients are at increased risk of bleeding, this question is crucial.

If nadroparin would be removed by filtration, removal is expected to depend on hemofiltration dose (to be greater with a higher dose)

We therefore designed a randomized controlled cross-over trial in the setting of critical illness and acute renal failure comparing the anticoagulant effect of nadroparin (anti-Xa) between two doses of CVVH in the patients blood, in the extracorporeal circuit and in the ultrafiltrate.

Because hemostasis in critically ill patients is not only influenced by anticoagulation but also by the critical illness and the extracorporeal circuit, we also measure other hemostatic markers, especially the endogenous thrombin potential (ETP), which seems the most global marker of hemostasis, incorporating procoagulant and anticoagulant effects.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

acute renal failure requiring renal replacement therapy

Exclusion Criteria:

(recent) bleeding or a suspicion of bleeding necessitating transfusion,
need of therapeutic anticoagulation or
(suspected) heparin-induced thrombocytopenia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965328

Locations

Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1090AC

Sponsors and Collaborators

Onze Lieve Vrouwe Gasthuis

Investigators

Principal Investigator:

Heleen Oudemans-van Straaten, MD.PhD

Onze Lieve Vrouwe Gasthuis

More Information

No publications provided by Onze Lieve Vrouwe Gasthuis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Oudemans-van Straaten HM, van Schilfgaarde M, Molenaar PJ, Wester JP, Leyte A. Hemostasis during low molecular weight heparin anticoagulation for continuous venovenous hemofiltration: a randomized cross-over trial comparing two hemofiltration rates. Crit Care. 2009;13(6):R193. Epub 2009 Dec 3.

Responsible Party:	HM Oudemans-van Straaten, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:	NCT00965328 History of Changes
Other Study ID Numbers:	WO 06044
Study First Received:	August 24, 2009
Last Updated:	August 24, 2009
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Onze Lieve Vrouwe Gasthuis:

anticoagulation
hemofiltration
acute kidney injury
heparin

hemostasis
nadroparin
anti-Xa
endogenous thrombin potential

Additional relevant MeSH terms:

Acute Kidney Injury
Multiple Organ Failure
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Shock
Pathologic Processes
Nadroparin

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 June 18, 2013