Critical IllnessNADRONCT05926518
Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients
An observational study of Critical Illness and Therapeutic Drug Monitoring, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients. Secondary objectives 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Therapeutic Drug Monitoring, Venous Thromboembolism
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2020to 23 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult ICU patients (COVID-19 and non-COVID-19 patients) using nadroparin with the intention of thrombosis prophylaxis are included. Anti Xa activity is determined once per patient at least 3 days (peak level after 4th administration) after admission at the ICU and on nadroparin treatment. No randomization.
Who may be able to join
- All COVID-19 patients > 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc
- All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc.
- Minimum estimated length of stay on the ICU of 4 days
Who cannot join
- o (History of) Heparin Induced Thrombocytopenia and Thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU
Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients.
Secondary objectives
- To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups.
- To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.
- Being tested
- blood sampling
- Medical subject headings
- Critical Illness, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
Blood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ICU patients | Patients were administered as standard care once daily nadroparin 5700 IU sc (below 100 kg) or twice daily nadroparin 5700 IU sc (above 100 kg). Receives: Procedure: blood sampling | |
| non-COVID-19 ICU patients | Patients were administered as standard care once daily nadroparin 2850 IU sc. Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of anti-Xa peak level
U/ml
Measured: 2 years
Secondary outcomes (2)
Percentage of anti-Xa levels within target range
Amount of levels within target range (in %)
Measured: 2 years
Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level
relevant correlation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Nov 2020
- Primary completion1 Apr 2022
- Study completion23 Nov 2022
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926518
- Sponsor's protocol ID
- 2020/1725
- Acronym
- NADRO
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU
- ClinicalTrials.gov ID
- NCT05926518
- Acronym / sponsor ID
- NADRO / 2020/1725
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 3 Jul 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.
Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients.
Secondary objectives
- To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups.
- To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ICU patients | – | Procedure: blood samplingPatients were administered as standard care once daily nadroparin 5700 IU sc (below 100 kg) or twice daily nadroparin 5700 IU sc (above 100 kg). |
| non-COVID-19 ICU patients | – | Procedure: blood samplingPatients were administered as standard care once daily nadroparin 2850 IU sc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult ICU patients (COVID-19 and non-COVID-19 patients) using nadroparin with the intention of thrombosis prophylaxis are included. Anti Xa activity is determined once per patient at least 3 days (peak level after 4th administration) after admission at the ICU and on nadroparin treatment. No randomization.
Key inclusion criteria (3 listed)
- All COVID-19 patients > 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc
- All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc.
- Minimum estimated length of stay on the ICU of 4 days
Key exclusion criteria (1 listed)
- o (History of) Heparin Induced Thrombocytopenia and Thrombosis
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 |
|---|---|---|
| blood samplingBlood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc. | Procedure or surgery | COVID-19 ICU patients, non-COVID-19 ICU patients |
Primary outcome
Evaluation of anti-Xa peak level
Time frame: 2 years
U/ml
2 secondary outcomes
Percentage of anti-Xa levels within target range
Time frame: 2 years
Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level
Time frame: 2 years
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 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Therapeutic Drug Monitoring, run by Rijnstate Hospital at 1 site in Netherlands.
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 1 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 3 Jul 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 Netherlands. 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?
Evaluation of anti-Xa peak level (time frame: 2 years). 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 Jul 2023.