Nadroparin Anticoagulation for Continuous Venovenous Hemo... | NCT00965328

Studies
Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration

NCT00965328

Sponsor

Onze Lieve Vrouwe Gasthuis

Status

Completed

Last Update Posted

Aug 25, 2009Estimated

Enrollment

14Actual

Phase

Phase 4

Conditions

Kidney
Acute Renal Failure
Multiple Organ Failure

Interventions

CVVH 4 to 2 L/h
CVVH 2 to 4L/h

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2009

Last Update Posted Date

Aug 25, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Onze Lieve Vrouwe GasthuisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CVVH 4 to 2 L/h	Procedure	CVVH is initiated at 4L/h and is converted to 2L/h after 60 min	hemofiltration at 4L/h

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes		24 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heleen Oudemans-van Straaten, MD.PhD	Onze Lieve Vrouwe Gasthuis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Onze Lieve Vrouwe Gasthuis		Amsterdam		1090AC	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36416787	Derived	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.
34519356	Derived	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.

ID	Term
D058186	Acute Kidney Injury
D009102	Multiple Organ Failure

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative