KidneyPhase 4NCT00965328
Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration
A Phase 4 study testing CVVH 4 to 2 L/h and CVVH 2 to 4L/h in people with Kidney and Acute Renal Failure, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney, Acute Renal Failure, Multiple Organ Failure
- What is being tested?
- CVVH 4 to 2 L/h and CVVH 2 to 4L/h
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2007to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute renal failure requiring renal replacement therapy
Who cannot join
- (recent) bleeding or a suspicion of bleeding necessitating transfusion,
- need of therapeutic anticoagulation or
- (suspected) heparin-induced thrombocytopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
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
Read the 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.
- Conditions
- Kidney, Acute Renal Failure, Multiple Organ Failure
- Being tested
- CVVH 4 to 2 L/h, CVVH 2 to 4L/h
- Keywords
- anticoagulation, hemofiltration, acute kidney injury, heparin, hemostasis, nadroparin, anti-Xa, endogenous thrombin potential
- Medical subject headings
- Acute Kidney Injury, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVH 4 to 2 L/hProcedure or surgery
Also called continuous venovenous hemofiltration
CVVH is initiated at 4L/h and is converted to 2L/h after 60 min
CVVH 2 to 4L/hProcedure or surgery
Also called continous venovenous hemofiltration
CVVH is initiated at 2L/h and is converted to 4L/h after 60 min
| Study group | Role | What they receive |
|---|---|---|
| hemofiltration at 4L/h | Active comparator | Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration Receives: 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 Receives: Procedure: CVVH 2 to 4L/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.
Measured: 24 hours
Secondary outcomes (1)
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startFeb 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Investigators
- Heleen Oudemans-van Straaten, MD.PhD, Principal investigator, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965328
- Sponsor's protocol ID
- WO 06044
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36416787Tsujimoto 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.
PubMed 34519356Tsujimoto 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.
PubMed 33314078Oudemans-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.
PubMed 19958532
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
- ClinicalTrials.gov ID
- NCT00965328
- Acronym / sponsor ID
- WO 06044
- Conditions
- Kidney, Acute Renal Failure, Multiple Organ Failure
- Keywords
- anticoagulation, hemofiltration, acute kidney injury, heparin, hemostasis, nadroparin, anti-Xa, endogenous thrombin potential
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemofiltration at 4L/h | Active comparator | Procedure: CVVH 4 to 2 L/hHemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration |
| hemofiltration at 2L/h | Active comparator | Procedure: CVVH 2 to 4L/hhemofiltration was started at 2L/h and crossed over to 4L/h after 60 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute renal failure requiring renal replacement therapy
Key exclusion criteria (3 listed)
- (recent) bleeding or a suspicion of bleeding necessitating transfusion,
- need of therapeutic anticoagulation or
- (suspected) heparin-induced thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVVH 4 to 2 L/hAlso: continuous venovenous hemofiltrationCVVH is initiated at 4L/h and is converted to 2L/h after 60 min | Procedure or surgery | hemofiltration at 4L/h |
| CVVH 2 to 4L/hAlso: continous venovenous hemofiltrationCVVH is initiated at 2L/h and is converted to 4L/h after 60 min | Procedure or surgery | hemofiltration at 2L/h |
Primary outcome
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.
Time frame: 24 hours
1 secondary outcome
Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Derived from this study: PubMed 36416787Fayad 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.
- Derived from this study: PubMed 34519356Tsujimoto 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.
- Derived from this study: PubMed 33314078Tsujimoto 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.
- Derived from this study: PubMed 19958532Oudemans-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heleen Oudemans-van Straaten, MD.PhD principal investigator
Onze Lieve Vrouwe Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CVVH 4 to 2 L/h and CVVH 2 to 4L/h in people with Kidney and Acute Renal Failure, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00965328, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.