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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00965328
Other study ID # WO 06044
Secondary ID
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


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
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