ThromboprophylaxisAKI-ENOXANCT07384598
Pharmacokinetic Profiles of Subcutaneous Enoxaparin for Thromboprophylaxis in Critically Ill Patients With Renal Failure Treated or Not With Continuous Veno-veinous Hemofiltration.
A study testing Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin in people with Thromboprophylaxis and Critical Illness, run by Clinique Saint Pierre Ottignies.
Trial summary
Thromboprophylaxis is recommended for critically ill patients without contraindications and is usually achieved by the subcutaneous daily administration of a low dose of low molecular weight heparin (LMWH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboprophylaxis, Critical Illness, Intensive Care (ICU)
- What is being tested?
- Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 year old
- Hospitalized in the ICU.
- Equiped with an arterial line.
- Indication for thromboprophylaxis with a daily prophylactic dose of enoxaparin.
- Additionnally:
- For cohort 1: severe renal failure (KDIGO stage ≥2) without CVVH AND SOFA score ≥4.
- For cohort 2: severe renal failure (KDIGO stage ≥2) with CVVH AND sequential organ failure assessment (SOFA) score ≥4.
- For cohort 3: no renal failure (creatinine clearance > 60 ml/min)
Who cannot join
- Platelet count < 50 000/μl.
- CHILD PUGH stage C cirrhosis.
- Known coagulation disorder.
- Patient treated in the last 3 days with direct oral anticoagulants.
- Patient treated in the last 24h with LMWH before enrollment.
- High bleeding risk with contra indication for standard dose of LMWH prophylaxis, as per investigator judgment
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- Indication for therapeutic anticoagulation (including CVVH with systemic heparin anticoagulation).
- Body weight < 50 kg or > 120 kg.
- Evidence of recovery of renal function before enrollment, based on investigator judgement.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Thromboprophylaxis is recommended for critically ill patients without contraindications and is usually achieved by the subcutaneous daily administration of a low dose of low molecular weight heparin (LMWH). The efficacy of this measure can be assessed by measuring the anticoagulation level obtained in the blood by dosing the anti-Xa activity. However, multiple studies have shown that anti-Xa activities in critically ill patients in the intensive care unit (ICU) are much lower, and below the desired range, than their ward counterparts.
LMWH elimination depends on kidney function and reduced dosing is recommended for patients with renal failure, treated or not with renal replacement therapy (continuous veno-venous hemofiltration (CVVH)). However, some scarce data suggest that even critically ill patients with renal failure treated with reduced or even with standard doses of LMWH, also have lower anti-Xa activities (below the desired range). If confirmed, this finding may suggest that reduced or even standard dosing of LMWH for thromboprophylaxis in critically ill patients with renal failure should be replaced by another dosing regimen or another route of administration. Therefore, this study aims to better characterize the pharmacokinetic profiles of LMWH after administration of a prophylactic dose of enoxaparin daily in patients with renal failure treated or not with CVVH, and to compare them to patients with no renal failure.
- Conditions
- Thromboprophylaxis, Critical Illness, Intensive Care (ICU)
- Being tested
- Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin
- Keywords
- thromboprophylaxis
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparinDiagnostic test
Monitoring of the antifactor Xa activity will be performed immediately before (H0), 4(H4), 8(H8), 12 (H12), and 24 (H24) hours after up to 3 doses of LMWH administration.
| Study group | Role | What they receive |
|---|---|---|
| Thromboprophylaxis arm | Experimental | Participating subjects will be given a prophylactic dose of enoxaparin, via the subcutaneous route, as standard of care. The enoxaparin dose will be defined according to the actual patient's body weight as follow: 40 mg daily for patients between 60 and 100 kg, 30 mg daily for patient < 60 kg and 50 mg daily for patients > 100 kg. Receives: Diagnostic Test: Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean peak anti-Xa activity
The primary endpoint will be the difference in the mean peak anti-Xa activity 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin in critically ill patients with renal failure without CVVH (N=20), in patients with renal failure with CVVH (N=20) and in a control group of patients with no renal failure (N=20).
Measured: 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin
Secondary outcomes (2)
Mean area under the curve (AUC) (0-24 hours) of anti-Xa activity
Measured: 0-24 hours after the subcutaneous administration of a prophylactic dose of enoxaparin
Trough value of anti-Xa activity
Measured: Trough value of anti-Xa activity 24 hours after the injection of a prophylactic dose of enoxaparin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboprophylaxisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Pierre Ottignies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas De Schryver, Clinique Saint Pierre Ottignies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384598
- Sponsor's protocol ID
- AKI-ENOXA
- Acronym
- AKI-ENOXA
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no intention to share IPD for this trial.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Profiles of Subcutaneous Enoxaparin for Thromboprophylaxis in Critically Ill Patients With Renal Failure Treated or Not With Continuous Veno-veinous Hemofiltration.
- ClinicalTrials.gov ID
- NCT07384598
- Acronym / sponsor ID
- AKI-ENOXA / AKI-ENOXA
- Conditions
- Thromboprophylaxis, Critical Illness, Intensive Care (ICU)
- Keywords
- thromboprophylaxis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique Saint Pierre OttigniesUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- 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.
Thromboprophylaxis is recommended for critically ill patients without contraindications and is usually achieved by the subcutaneous daily administration of a low dose of low molecular weight heparin (LMWH). The efficacy of this measure can be assessed by measuring the anticoagulation level obtained in the blood by dosing the anti-Xa activity. However, multiple studies have shown that anti-Xa activities in critically ill patients in the intensive care unit (ICU) are much lower, and below the desired range, than their ward counterparts.
LMWH elimination depends on kidney function and reduced dosing is recommended for patients with renal failure, treated or not with renal replacement therapy (continuous veno-venous hemofiltration (CVVH)). However, some scarce data suggest that even critically ill patients with renal failure treated with reduced or even with standard doses of LMWH, also have lower anti-Xa activities (below the desired range). If confirmed, this finding may suggest that reduced or even standard dosing of LMWH for thromboprophylaxis in critically ill patients with renal failure should be replaced by another dosing regimen or another route of administration. Therefore, this study aims to better characterize the pharmacokinetic profiles of LMWH after administration of a prophylactic dose of enoxaparin daily in patients with renal failure treated or not with CVVH, and to compare them to patients with no renal failure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thromboprophylaxis arm | Experimental | Diagnostic Test: Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparinParticipating subjects will be given a prophylactic dose of enoxaparin, via the subcutaneous route, as standard of care. The enoxaparin dose will be defined according to the actual patient's body weight as follow: 40 mg daily for patients between 60 and 100 kg, 30 mg daily for patient < 60 kg and 50 mg daily for patients > 100 kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 year old
- Hospitalized in the ICU.
- Equiped with an arterial line.
- Indication for thromboprophylaxis with a daily prophylactic dose of enoxaparin.
- Additionnally:
Key exclusion criteria (9 listed)
- Platelet count < 50 000/μl.
- CHILD PUGH stage C cirrhosis.
- Known coagulation disorder.
- Patient treated in the last 3 days with direct oral anticoagulants.
- Patient treated in the last 24h with LMWH before enrollment.
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 |
|---|---|---|
| Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparinMonitoring of the antifactor Xa activity will be performed immediately before (H0), 4(H4), 8(H8), 12 (H12), and 24 (H24) hours after up to 3 doses of LMWH administration. | Diagnostic test | Thromboprophylaxis arm |
Primary outcome
mean peak anti-Xa activity
Time frame: 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin
The primary endpoint will be the difference in the mean peak anti-Xa activity 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin in critically ill patients with renal failure without CVVH (N=20), in patients with renal failure with CVVH (N=20) and in a control group of patients with no renal failure (N=20).
2 secondary outcomes
Mean area under the curve (AUC) (0-24 hours) of anti-Xa activity
Time frame: 0-24 hours after the subcutaneous administration of a prophylactic dose of enoxaparin
Trough value of anti-Xa activity
Time frame: Trough value of anti-Xa activity 24 hours after the injection of a prophylactic dose of enoxaparin.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. There is no intention to share IPD for this trial.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin in people with Thromboprophylaxis and Critical Illness, run by Clinique Saint Pierre Ottignies.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas De Schryver, MD (+3210737251, nicolas.deschryver@cspo.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean peak anti-Xa activity (time frame: 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin). 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 Feb 2026.