Dose Adjustment of Enoxaparin in ICU PatientsNCT05221879
Anti-factor Xa Based Venous Thromboembolism Prophylaxis
A study testing Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a in people with Dose Adjustment of Enoxaparin in ICU Patients, run by Meir Medical Center at 1 site in Israel.
Trial summary
Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dose Adjustment of Enoxaparin in ICU Patients
- What is being tested?
- Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jun 2019to 15 Feb 2021
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Inclusion criteria were age over 18 years and a predicted ICU stay of more than 72 h.
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Exclusion Criteria: Exclusion criteria were any contraindication for heparin-based thromboembolic prophylaxis, patients with an indication for therapeutic anticoagulation , administration of unfractioned-heparin or low-molecular-weight-heparin prior to study entry, active hemorrhage, or creatinine clearance < 30 mL/min.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-factor Xa Based Venous Thromboembolism Prophylaxis: Dose Adjustment in ICU Patients
Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above
- Being tested
- Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10aOther
We screened ICU patients who recieved DVT prophylaxis with fixed dose of Enoxaparin (40 mg SC daily) for peak blood levels of factor 10A. For patients who did not achieve therapuetic 10a levels (0.2-0.4) we increased the Enoxaparin dose to 60 mg SC daily.
| Study group | Role | What they receive |
|---|---|---|
| Patients with target factor 10a levels | No intervention | Patients with target factor 10a levels continued to recieve the standard Enoxaparin dose of 40 mg SC daily. |
| Patients with sub-therapuetic factor 10a levels | Other | In patients with sub-therapuetic factor 10a levels we increased the Enoxaparin dose to 60 mg SC daily. Receives: Other: Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin
We measured peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin among ICU patients who recieved enoxaparin for VTE prophylaxis..
Measured: Up to 72 hours from ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start23 Jun 2019
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dose Adjustment of Enoxaparin in ICU PatientsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221879
- Sponsor's protocol ID
- MMC-18-0262
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-factor Xa Based Venous Thromboembolism Prophylaxis: Dose Adjustment in ICU Patients
- ClinicalTrials.gov ID
- NCT05221879
- Acronym / sponsor ID
- MMC-18-0262
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 23 Jun 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 3 Feb 2022 (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.
Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with target factor 10a levels | No intervention | –Patients with target factor 10a levels continued to recieve the standard Enoxaparin dose of 40 mg SC daily. |
| Patients with sub-therapuetic factor 10a levels | Other | Other: Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10aIn patients with sub-therapuetic factor 10a levels we increased the Enoxaparin dose to 60 mg SC daily. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10aWe screened ICU patients who recieved DVT prophylaxis with fixed dose of Enoxaparin (40 mg SC daily) for peak blood levels of factor 10A. For patients who did not achieve therapuetic 10a levels (0.2-0.4) we increased the Enoxaparin dose to 60 mg SC daily. | Other | Patients with sub-therapuetic factor 10a levels |
Primary outcome
Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin
Time frame: Up to 72 hours from ICU admission.
We measured peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin among ICU patients who recieved enoxaparin for VTE prophylaxis..
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 3 Feb 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a in people with Dose Adjustment of Enoxaparin in ICU Patients, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Feb 2022. 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 Israel. 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.
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 aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin (time frame: Up to 72 hours from ICU admission.). 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 2022.