Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965328
• Other study ID #: WO 06044
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2009
• Last updated: August 24, 2009
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: August 2009
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Kidney
• Multiple Organ Failure

Intervention

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

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.		24 hours	Yes
Secondary	Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes		24 hours	Yes