Contra-Indication to the Use of Low Molecular Weight HeparinPhase 3HDSHNCT00473109
Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study
A Phase 3 study testing Dialysis without systemic heparinization in people with Contra-Indication to the Use of Low Molecular Weight Heparin, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contra-Indication to the Use of Low Molecular Weight Heparin
- What is being tested?
- Dialysis without systemic heparinization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to May 2009
- 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
- Chronic hemodialysis patient
- Low molecular weight heparin contra indicated for at least 3 consecutive hemodialysis sessions.
Who cannot join
- Acute renal failure
- Access flow < 250 ml/mn)
- Per dialytic Blood transfusion or parenteral nutritional support
- Systolic BP < 80 mm Hg
- Hemoglobin > 13 g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").
Read the detailed description
Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").
We propose a monocentric prospective randomized open study to compare " rises ", " pre-dilution " and " heparin adsorption " in chronic hemodialysis patients with contra-indication to the use of LMWH. Main criteria will be extra-corporeal circuit clotting, with dialysis efficiency and tolerance as secondary criteria. Comparison will be made on grounds of " n-of-1 " trial, i.e. series of randomized cross-over tests in individuals. We have planned to include 75 patients in this study, with 1050 LMWH-free dialysis sessions.
We hope to demonstrate chat by comparison wit rises, pre-dilution and heparin absorption techniques reduce the rate of extra-corporeal circuit by 30 and 50% respectively. We also hope to show that heparin adsorption (i) better preserves membrane integrity throughout the dialysis session, resulting in enhanced dialysis efficiency ; (ii) avoids extra fluid infusion and ultrafiltration, resulting in better dry weigh achievement and better clinical tolerance.
- Being tested
- Dialysis without systemic heparinization
- Keywords
- Hemodialysis, Heparin, Clotting
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis without systemic heparinizationProcedure or surgery
Dialysis without systemic heparinization
| Study group | Role | What they receive |
|---|---|---|
| Dialysis without systemic heparinization | Experimental | Dialysis without systemic heparinization Receives: Procedure: Dialysis without systemic heparinization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit
Measured: during dialises
or coagulation partial of the circuit (a clot is noted in the lines or the trap with bubbles
Measured: during dialeses
-or increase in the venous pressure (statement) of the circuit of more than 50 that is to say increase in the venous pressure (statement) of the circuit of more than 50 % beyond its initial value
Measured: during the dialeses
Secondary outcomes (4)
Loss of effectiveness of dialysis? dialysance of urea during the meeting (online measurement carried out by the generator of dialysis)
Measured: during the dialeses
Loss of effectiveness of dialysis overloads hydro-sodic persistent (weight of the patient at the end of the meeting: + 500 grams compared to the basic weight)
Measured: during the dialeses
Tolerance of the meeting of dialysis clinical side effects (cephalgias, cramps, arterial hypotension
Measured: during the dialeses
Tolerance of the meeting of dialysis hemorrhagic accidents to at the time the 48 hours following the meeting of dialysis
Measured: 48 hours following the meeting of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contra-Indication to the Use of Low Molecular Weight HeparinStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Dominique JOLY, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473109
- Sponsor's protocol ID
- P050311
- Other IDs
- CRC05032
- Acronym
- HDSH
- Status last verified
- May 2007
- First submitted
- 11 May 2007
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PubMed 38189593Guery B, Alberti C, Servais A, Harrami E, Bererhi L, Zins B, Touam M, Joly D. Hemodialysis without systemic anticoagulation: a prospective randomized trial to evaluate 3 strategies in patients at risk of bleeding. PLoS One. 2014 May 13;9(5):e97187. doi: 10.1371/journal.pone.0097187. eCollection 2014.
PubMed 24825343
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study
- ClinicalTrials.gov ID
- NCT00473109
- Acronym / sponsor ID
- HDSH / P050311
- Keywords
- Hemodialysis, Heparin, Clotting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 May 2007 (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.
Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").
Detailed description
Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").
We propose a monocentric prospective randomized open study to compare " rises ", " pre-dilution " and " heparin adsorption " in chronic hemodialysis patients with contra-indication to the use of LMWH. Main criteria will be extra-corporeal circuit clotting, with dialysis efficiency and tolerance as secondary criteria. Comparison will be made on grounds of " n-of-1 " trial, i.e. series of randomized cross-over tests in individuals. We have planned to include 75 patients in this study, with 1050 LMWH-free dialysis sessions.
We hope to demonstrate chat by comparison wit rises, pre-dilution and heparin absorption techniques reduce the rate of extra-corporeal circuit by 30 and 50% respectively. We also hope to show that heparin adsorption (i) better preserves membrane integrity throughout the dialysis session, resulting in enhanced dialysis efficiency ; (ii) avoids extra fluid infusion and ultrafiltration, resulting in better dry weigh achievement and better clinical tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis without systemic heparinization | Experimental | Procedure: Dialysis without systemic heparinizationDialysis without systemic heparinization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic hemodialysis patient
- Low molecular weight heparin contra indicated for at least 3 consecutive hemodialysis sessions.
Key exclusion criteria (5 listed)
- Acute renal failure
- Access flow < 250 ml/mn)
- Per dialytic Blood transfusion or parenteral nutritional support
- Systolic BP < 80 mm Hg
- Hemoglobin > 13 g/dl
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 |
|---|---|---|
| Dialysis without systemic heparinizationDialysis without systemic heparinization | Procedure or surgery | Dialysis without systemic heparinization |
Primary outcome
Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit
Time frame: during dialises
or coagulation partial of the circuit (a clot is noted in the lines or the trap with bubbles
Time frame: during dialeses
-or increase in the venous pressure (statement) of the circuit of more than 50 that is to say increase in the venous pressure (statement) of the circuit of more than 50 % beyond its initial value
Time frame: during the dialeses
4 secondary outcomes
Loss of effectiveness of dialysis? dialysance of urea during the meeting (online measurement carried out by the generator of dialysis)
Time frame: during the dialeses
Loss of effectiveness of dialysis overloads hydro-sodic persistent (weight of the patient at the end of the meeting: + 500 grams compared to the basic weight)
Time frame: during the dialeses
Tolerance of the meeting of dialysis clinical side effects (cephalgias, cramps, arterial hypotension
Time frame: during the dialeses
Tolerance of the meeting of dialysis hemorrhagic accidents to at the time the 48 hours following the meeting of dialysis
Time frame: 48 hours following the meeting of dialysis
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 May 2009.
- Derived from this study: PubMed 38189593Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
- Derived from this study: PubMed 24825343Guery B, Alberti C, Servais A, Harrami E, Bererhi L, Zins B, Touam M, Joly D. Hemodialysis without systemic anticoagulation: a prospective randomized trial to evaluate 3 strategies in patients at risk of bleeding. PLoS One. 2014 May 13;9(5):e97187. doi: 10.1371/journal.pone.0097187. eCollection 2014.
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.
Dominique JOLY, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Dialysis without systemic heparinization in people with Contra-Indication to the Use of Low Molecular Weight Heparin, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 5 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 May 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 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?
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?
Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit (time frame: during dialises). The study lists 3 primary outcomes in all. 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 NCT00473109, which also lists 2 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 May 2009.