Kidney FailurePhase 3NCT00242398
Hemodialysis Without Anticoagulation in Intensive Care Unit
A Phase 3 study testing AN69 ST in people with Kidney Failure and Critically Ill, run by Centre Hospitalier Départemental at 1 site in France.
Trial summary
The purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high risk of bleeding Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Critically Ill, Hemorrhage
- What is being tested?
- AN69 ST
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2005to Apr 2008
- Phase
- Phase 3
- 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
- age > 18 years
- patient with high risk bleeding
- patient requiring dialytic therapy in intensive care unit
Who cannot join
- Pregnancy
- History of heparin-induced thrombocytopenia or serious heparin allergy
- History of serious membrane dialysis allergy
- Treatment by any of following medications 24H within the inclusion:
- prophylactic or therapeutic anticoagulation with unfractioned heparin or low molecular weight heparin nonsteroidal anti-inflammatory agents direct thrombin inhibitors, antithrombin concentrate, activated protein C, anti-factor Xa pentasaccharide
- Treatement by acetylsalicylic acid or other antiplatelet agent excluding platelet glycoprotein IIb/IIIa antagonists 7 days within the inclusion.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHD
La Roche-sur-Yon, 85925
Laurent Martin-Lefevre
Laurent Martin-Lefèvre
About this study
Official title: Heparin Free Hemodialysis for Patients With Bleeding High Risk in ICU. Randomized Study: Heparin Free Dialysis With Intermittent Saline Flushes Versus Heparin Free Dialysis With Nephral 400ST (AN69ST, Hospal, France)
The purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high risk of bleeding
Read the detailed description
Hemodialysis in patients who are at high risk of bleeding complications represents a challenge of balancing the needs for establishment of an adequately functioning extracorporeal circuit for dialytic therapy with the requirement of not exacerbating existing bleeding or precipitating bleeding in predisposed subjects.
Several methods of nonheparin dialysis have been used. The method most commonly used to effect such treatment is "saline flushing": saline boluses are delivred at frequent intervals. This method is far from optimal for several reasons, including failure to maintain a patent circuit in significant proportion of patients, an added logistic burden on dialysis nurses. An alternative method of avoiding systemic heparinization is priming the dialysis membrane with heparin before hemodialysis. The method is based on fact that AN69ST (Nephral 400ST , Hospal, France) dialysis membrane have a high affinity for binding heparin, and that the bound heparin exerts a localized antithrombotic effect without systemic spillover.
Comparison: heparin free hemodialysis with saline flushes compared heparin free hemodialysis with Nephral 400ST.
- Conditions
- Kidney Failure, Critically Ill, Hemorrhage
- Being tested
- AN69 ST
- Keywords
- Intensive care unit, Patients with bleeding high risk, Intermittent hemodialysis without anticoagulation, Blood lost
- Medical subject headings
- Renal Insufficiency, Critical Illness, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN69 STDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis.
Measured: at the end of the dialysis treatement
Secondary outcomes (3)
Blood lost associated with extracorporeal thrombosis or active bleeding
Measured: At the end of the dialysis treatment
Necessary time of nurse's work
Measured: During the dialysis treatment
Weight lost patients during dialysis treatment
Measured: At the end of dialysis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startOct 2005
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Départemental
- Sponsor type
- University, hospital or other
- Investigators
- Laurent Martin-Lefèvre, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242398
- Sponsor's protocol ID
- HDI-FH
- Status last verified
- Oct 2007
- First submitted
- 18 Oct 2005
- Last updated
- 3 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Free Hemodialysis for Patients With Bleeding High Risk in ICU. Randomized Study: Heparin Free Dialysis With Intermittent Saline Flushes Versus Heparin Free Dialysis With Nephral 400ST (AN69ST, Hospal, France)
- ClinicalTrials.gov ID
- NCT00242398
- Acronym / sponsor ID
- HDI-FH
- Conditions
- Kidney Failure, Critically Ill, Hemorrhage
- Keywords
- Intensive care unit, Patients with bleeding high risk, Intermittent hemodialysis without anticoagulation, Blood lost
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier DépartementalUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Apr 2008 (estimated)
- First posted
- 20 Oct 2005 (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 purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high risk of bleeding
Detailed description
Hemodialysis in patients who are at high risk of bleeding complications represents a challenge of balancing the needs for establishment of an adequately functioning extracorporeal circuit for dialytic therapy with the requirement of not exacerbating existing bleeding or precipitating bleeding in predisposed subjects.
Several methods of nonheparin dialysis have been used. The method most commonly used to effect such treatment is "saline flushing": saline boluses are delivred at frequent intervals. This method is far from optimal for several reasons, including failure to maintain a patent circuit in significant proportion of patients, an added logistic burden on dialysis nurses. An alternative method of avoiding systemic heparinization is priming the dialysis membrane with heparin before hemodialysis. The method is based on fact that AN69ST (Nephral 400ST , Hospal, France) dialysis membrane have a high affinity for binding heparin, and that the bound heparin exerts a localized antithrombotic effect without systemic spillover.
Comparison: heparin free hemodialysis with saline flushes compared heparin free hemodialysis with Nephral 400ST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- patient with high risk bleeding
- patient requiring dialytic therapy in intensive care unit
Key exclusion criteria (6 listed)
- Pregnancy
- History of heparin-induced thrombocytopenia or serious heparin allergy
- History of serious membrane dialysis allergy
- Treatment by any of following medications 24H within the inclusion:
- prophylactic or therapeutic anticoagulation with unfractioned heparin or low molecular weight heparin nonsteroidal anti-inflammatory agents direct thrombin inhibitors, antithrombin concentrate, activated protein C, anti-factor Xa pentasaccharide
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 |
|---|---|---|
| AN69 ST | Device | – |
Primary outcome
Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis.
Time frame: at the end of the dialysis treatement
3 secondary outcomes
Blood lost associated with extracorporeal thrombosis or active bleeding
Time frame: At the end of the dialysis treatment
Necessary time of nurse's work
Time frame: During the dialysis treatment
Weight lost patients during dialysis treatment
Time frame: At the end of dialysis treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2007.
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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.
Laurent Martin-Lefèvre principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AN69 ST in people with Kidney Failure and Critically Ill, run by Centre Hospitalier Départemental at 1 site in France.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Oct 2007. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Martin-Lefèvre, MD (33(0)251446088, laurent.martin-lefevre@chd-vendee.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis. (time frame: at the end of the dialysis treatement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2007.