Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration
Primary Purpose
Kidney, Acute Renal Failure, Multiple Organ Failure
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
CVVH 4 to 2 L/h
CVVH 2 to 4L/h
Sponsored by
About this trial
This is an interventional treatment trial for Kidney focused on measuring anticoagulation, hemofiltration, acute kidney injury, heparin, hemostasis, nadroparin, anti-Xa, endogenous thrombin potential
Eligibility Criteria
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
Sites / Locations
- Onze Lieve Vrouwe Gasthuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
hemofiltration at 4L/h
hemofiltration at 2L/h
Arm Description
Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration
hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min
Outcomes
Primary Outcome Measures
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.
Secondary Outcome Measures
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes
Full Information
NCT ID
NCT00965328
First Posted
August 24, 2009
Last Updated
August 24, 2009
Sponsor
Onze Lieve Vrouwe Gasthuis
1. Study Identification
Unique Protocol Identification Number
NCT00965328
Brief Title
Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration
Official Title
Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Onze Lieve Vrouwe Gasthuis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
whether nadroparin accumulates in plasma
whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney, Acute Renal Failure, Multiple Organ Failure
Keywords
anticoagulation, hemofiltration, acute kidney injury, heparin, hemostasis, nadroparin, anti-Xa, endogenous thrombin potential
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hemofiltration at 4L/h
Arm Type
Active Comparator
Arm Description
Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration
Arm Title
hemofiltration at 2L/h
Arm Type
Active Comparator
Arm Description
hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min
Intervention Type
Procedure
Intervention Name(s)
CVVH 4 to 2 L/h
Other Intervention Name(s)
continuous venovenous hemofiltration
Intervention Description
CVVH is initiated at 4L/h and is converted to 2L/h after 60 min
Intervention Type
Procedure
Intervention Name(s)
CVVH 2 to 4L/h
Other Intervention Name(s)
continous venovenous hemofiltration
Intervention Description
CVVH is initiated at 2L/h and is converted to 4L/h after 60 min
Primary Outcome Measure Information:
Title
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heleen Oudemans-van Straaten, MD.PhD
Organizational Affiliation
Onze Lieve Vrouwe Gasthuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1090AC
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
34519356
Citation
Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
Results Reference
derived
PubMed Identifier
33314078
Citation
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Results Reference
derived
PubMed Identifier
19958532
Citation
Oudemans-van Straaten HM, van Schilfgaarde M, Molenaar PJ, Wester JP, Leyte A. Hemostasis during low molecular weight heparin anticoagulation for continuous venovenous hemofiltration: a randomized cross-over trial comparing two hemofiltration rates. Crit Care. 2009;13(6):R193. doi: 10.1186/cc8191. Epub 2009 Dec 3.
Results Reference
derived
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Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration
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