NCT00965328

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. 1.whether nadroparin accumulates in plasma
  2. 2.whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
  3. 3.the effects of nadroparin during critical illness on coagulation and anticoagulation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

1.2 years

First QC Date

August 24, 2009

Last Update Submit

August 24, 2009

Conditions

KidneyAcute Renal FailureMultiple Organ Failure

Keywords

anticoagulationhemofiltrationacute kidney injuryheparinhemostasisnadroparinanti-Xaendogenous thrombin potential

Outcome Measures

Primary Outcomes (1)

  • Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.

    24 hours

Secondary Outcomes (1)

  • Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes

    24 hours

Study Arms (2)

hemofiltration at 4L/h

ACTIVE COMPARATOR

Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration

Procedure: CVVH 4 to 2 L/h

hemofiltration at 2L/h

ACTIVE COMPARATOR

hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min

Procedure: CVVH 2 to 4L/h

Interventions

CVVH 4 to 2 L/hPROCEDURE

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

Also known as: continuous venovenous hemofiltration
hemofiltration at 4L/h
CVVH 2 to 4L/hPROCEDURE

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

Also known as: continous venovenous hemofiltration
hemofiltration at 2L/h

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute renal failure requiring renal replacement therapy

You may not qualify if:

  • (recent) bleeding or a suspicion of bleeding necessitating transfusion,
  • need of therapeutic anticoagulation or
  • (suspected) heparin-induced thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1090AC, Netherlands

Location

Related Publications (4)

  • Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

    PMID: 36416787DERIVED

  • 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.

    PMID: 34519356DERIVED

  • 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.

    PMID: 33314078DERIVED

  • 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.

    PMID: 19958532DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryMultiple Organ Failure

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Heleen Oudemans-van Straaten, MD.PhD

    Onze Lieve Vrouwe Gasthuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

February 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 25, 2009

Record last verified: 2009-08

Locations

NL(1)