Skip to content

Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00965328
Enrollment
14
Registered
2009-08-25
Start date
2007-02-28
Completion date
2008-05-31
Last updated
2009-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Kidney, Multiple Organ Failure

Keywords

anticoagulation, hemofiltration, acute kidney injury, heparin, hemostasis, nadroparin, anti-Xa, endogenous thrombin potential

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.

Interventions

PROCEDURECVVH 4 to 2 L/h

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

PROCEDURECVVH 2 to 4L/h

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

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.24 hours

Secondary

MeasureTime frame
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes24 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026