Critical IllnessPhase 4NCT04982055
Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients
A Phase 4 study testing Nadroparin (intravenous Infusion) and Nadroparin (subcutaneous group) in people with Critical Illness, run by Clinique Saint Pierre Ottignies.
Trial summary
Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Nadroparin (intravenous Infusion) and Nadroparin (subcutaneous group)
- 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
- 8 Apr 2015to 31 Dec 2020
- 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
- Adults patients > 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated
Who cannot join
- renal failure determined by glomerular filtration rate (GFR) < 30 ml/min or need for renal replacement therapy
- liver cirrhosis
- intravascular disseminated coagulation
- contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,…)
- patients receiving low dose of vasopressor (norepinephrine < 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)
About this study
Official title: Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial
Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients
Read the detailed description
The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.
- Conditions
- Critical Illness
- Being tested
- Nadroparin (intravenous Infusion), Nadroparin (subcutaneous group)
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nadroparin (intravenous Infusion)Drug
Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU
Nadroparin (subcutaneous group)Drug
Subcutaneous route of administration of nadroparin 3800 IU
| Study group | Role | What they receive |
|---|---|---|
| Intravenous group | Experimental | Not described Receives: Drug: Nadroparin (intravenous Infusion) |
| Subcutaneous group | Active comparator | Not described Receives: Drug: Nadroparin (subcutaneous group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak anti-Xa activity
Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
Measured: Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
Secondary outcomes (2)
Trough anti-Xa activity
Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
Measured: Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
AUC (0-24h)
Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start8 Apr 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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
- NCT04982055
- Sponsor's protocol ID
- IV vs SC LMWH ICU
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Schryver N, Serck N, Eeckhoudt S, Laterre PF, Wittebole X, Gerard L. Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial. J Crit Care. 2022 Aug;70:154029. doi: 10.1016/j.jcrc.2022.154029. Epub 2022 Apr 2.
PubMed 35381407
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04982055
- Acronym / sponsor ID
- IV vs SC LMWH ICU
- Conditions
- Critical Illness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinique Saint Pierre OttigniesUniversity, hospital or other
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jul 2021 (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.
Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients
Detailed description
The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous group | Experimental | Drug: Nadroparin (intravenous Infusion) |
| Subcutaneous group | Active comparator | Drug: Nadroparin (subcutaneous group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients > 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated
Key exclusion criteria (5 listed)
- renal failure determined by glomerular filtration rate (GFR) < 30 ml/min or need for renal replacement therapy
- liver cirrhosis
- intravascular disseminated coagulation
- contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,…)
- patients receiving low dose of vasopressor (norepinephrine < 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)
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 |
|---|---|---|
| Nadroparin (intravenous Infusion)Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU | Drug | Intravenous group |
| Nadroparin (subcutaneous group)Subcutaneous route of administration of nadroparin 3800 IU | Drug | Subcutaneous group |
Primary outcome
Peak anti-Xa activity
Time frame: Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration
2 secondary outcomes
Trough anti-Xa activity
Time frame: Trough anti-Xa activity measured 24 hours after start of low molecular weight administration
AUC (0-24h)
Time frame: 0-24 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 29 Jul 2021.
- Derived from this study: PubMed 35381407De Schryver N, Serck N, Eeckhoudt S, Laterre PF, Wittebole X, Gerard L. Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial. J Crit Care. 2022 Aug;70:154029. doi: 10.1016/j.jcrc.2022.154029. Epub 2022 Apr 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nadroparin (intravenous Infusion) and Nadroparin (subcutaneous group) in people with 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 1 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 29 Jul 2021. 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.
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?
Peak anti-Xa activity (time frame: Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration). 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 NCT04982055, which also lists 1 linked publication.
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 29 Jul 2021.