Critical IllnessNCT06055907
Influence of Vasopressors on Anti-Xa Activity in Critically Ill Patients
An observational study of Critical Illness and Thrombosis, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Critically ill patients require antithrombotic prophylaxis. At the same time, majority of them is receiving various vasopressors. The aim of the study is to determine whether there is a difference in anti-Xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness, Thrombosis
- What is being tested?
- Serum anti-Xa activity
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 15 May 2023to Sep 2024
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort study will be conducted on a population of 50 adult patients of both sexes treated in the Intensive Care Unit at the University Clinical Center in Gdansk, Poland.
Who may be able to join
- Circulatory failure
- Supported by continuous infusion of noradrenaline or noradrenaline and argipressin
- Receiving subcutaneous dalteparin for the prevention of venous thromboembolism.
Who cannot join
- Contraindications for dalteparin
- Severe coagulopathy
- Acute or subacute bacterial endocarditis
- Pregnant women
- BMI (body mass index) > 30kg/m2
- Chronic kidney disease with eGFR (estimated glomerular filtration rate) < 30 ml/min/1.73 m2
- Renal replacement therapy
- The patient died within 52 hours of starting VTE (venous thromboembolism) prophylaxis with dalteparin
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Gdansk, 80-214
Radosław Owczuk, MD, PhD, r.owczuk@gumed.edu.pl
About this study
Official title: Anti-Xa Activity in Patients Receiving Different Vasopressors.
Critically ill patients require antithrombotic prophylaxis. At the same time, majority of them is receiving various vasopressors. The aim of the study is to determine whether there is a difference in anti-Xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients receiving norepinephrine with argipressin, compared to those receiving norepinephrine alone.
- Conditions
- Critical Illness, Thrombosis
- Being tested
- Serum anti-Xa activity
- Medical subject headings
- Critical Illness, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum anti-Xa activityDiagnostic test
4 hours after third dose of dalteparin, serum anti-Xa activity is measured
| Study group | Role | What they receive |
|---|---|---|
| NOR+ARG | Critically ill patients receiving norepinephrine and argipressin, with antithrombotic prophylaxis with 5000 IU of dalteparin. Receives: Diagnostic Test: Serum anti-Xa activity | |
| NOR | Critically ill patients receiving norepinephrine alone, with antithrombotic prophylaxis with 5000 IU of dalteparin. Receives: Diagnostic Test: Serum anti-Xa activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Xa activity
IU anty-Xa/ml
Measured: 4 hours after third dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 May 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radosław Owczuk, MD., PhD., Prof., Study director, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055907
- Sponsor's protocol ID
- SKN+JS
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Xa Activity in Patients Receiving Different Vasopressors.
- ClinicalTrials.gov ID
- NCT06055907
- Acronym / sponsor ID
- SKN+JS
- Conditions
- Critical Illness, Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
Critically ill patients require antithrombotic prophylaxis. At the same time, majority of them is receiving various vasopressors. The aim of the study is to determine whether there is a difference in anti-Xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients receiving norepinephrine with argipressin, compared to those receiving norepinephrine alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOR+ARG | – | Diagnostic Test: Serum anti-Xa activityCritically ill patients receiving norepinephrine and argipressin, with antithrombotic prophylaxis with 5000 IU of dalteparin. |
| NOR | – | Diagnostic Test: Serum anti-Xa activityCritically ill patients receiving norepinephrine alone, with antithrombotic prophylaxis with 5000 IU of dalteparin. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort study will be conducted on a population of 50 adult patients of both sexes treated in the Intensive Care Unit at the University Clinical Center in Gdansk, Poland.
Key inclusion criteria (3 listed)
- Circulatory failure
- Supported by continuous infusion of noradrenaline or noradrenaline and argipressin
- Receiving subcutaneous dalteparin for the prevention of venous thromboembolism.
Key exclusion criteria (8 listed)
- Contraindications for dalteparin
- Severe coagulopathy
- Acute or subacute bacterial endocarditis
- Pregnant women
- BMI (body mass index) > 30kg/m2
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 |
|---|---|---|
| Serum anti-Xa activity4 hours after third dose of dalteparin, serum anti-Xa activity is measured | Diagnostic test | NOR, NOR+ARG |
Primary outcome
Anti-Xa activity
Time frame: 4 hours after third dose
IU anty-Xa/ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
Radosław Owczuk, MD., PhD., Prof. study director
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Thrombosis, run by Medical University of Gdansk at 1 site in Poland.
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 8 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 28 Sep 2023. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Stefaniak, MD. (505694054 ext. 0048, jan.stefaniak@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Xa activity (time frame: 4 hours after third dose). 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 28 Sep 2023.