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Completed

NCT Number: NCT00965328

Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CVVH 4 to 2 L/h

Procedure

CVVH is initiated at 4L/h and is converted to 2L/h after 60 min

Other names: continuous venovenous hemofiltration

CVVH 2 to 4L/h

Procedure

CVVH is initiated at 2L/h and is converted to 4L/h after 60 min

Other names: continous venovenous hemofiltration

Primary outcomes

  1. Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.

    Time frame: 24 hours

Secondary outcomes

  1. Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouwe Gasthuis

Other

Registry information

Official study title

Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 25, 2009
Registry last updated
Aug 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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