Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration

This study has been completed.
Sponsor:
Information provided by:
Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT00965328
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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

  1. whether nadroparin accumulates in plasma
  2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
  3. 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:


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):
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 April 17, 2014