Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration

Phase 4

Completed

• Conditions: Kidney; Acute Renal Failure; Multiple Organ Failure
• Interventions: Procedure: CVVH 2 to 4L/h; Procedure: CVVH 4 to 2 L/h

• Registration Number: NCT00965328
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Last Update Submitted: 2009-08-24
• Study First Posted: 2009-08-25
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hemofiltration at 2L/h	CVVH 2 to 4L/h	hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min
hemofiltration at 4L/h	CVVH 4 to 2 L/h	Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration

Primary Outcome Measures

Name	Time	Method
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.	24 hours

Secondary Outcome Measures

Name	Time	Method
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes	24 hours

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands