ThrombosisNCT05621915
Nadroparin Pharmacokinetics in Different Stages of COVID-19
An observational study of Thrombosis and Nadroparin, run by Medical University of Lublin at 1 site in Poland.
Trial summary
Objective: The risk of thrombotic complications in critical COVID-19 patients remains extremely high, and multicenter trials failed to prove the survival benefit of escalated doses of low molecular weight heparins (LMWH) in this group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombosis, Nadroparin, COVID-19
- What is being tested?
- Nadroparin
- Type of treatment
- Injection or infusion
- How many people
- 43 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2021to 15 Apr 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 Any age
- Child, Adult, Older adult
Study population: First group (Group 1) consisted of 14 patients treated with conventional oxygen therapy only in the infectious diseases department. The second group (Group 2) consisted of 14 mechanically ventilated patients treated in the ICU, and the third group (Group 3) was formed by 15 patients supported with extracorporeal membrane oxygenation (ECMO) and mechanically ventilated in the ICU. The investigators used surviving sepsis campaign guidelines for COVID-19 for the escalation of treatment in the study population.
Who may be able to join
- Patients treated in the Department of Anesthesiology and Intensive Care and the Department of Infectious Diseases of a tertiary academic hospital with confirmed SARS-CoV-2 infection with a real-time reverse transcription polymerase chain reaction (RT-PCR) or an antigen test.
Who cannot join
- Coagulation disorders at the start of the therapy.
Trial locations and contacts
1 site in 1 country.
Poland1 site
2nd Department of Anesthesiology and Critical Care, Medical University of Lublin
Lublin, Lublin Voivodeship, 20-059
About this study
Official title: Nadroparin Pharmacokinetics in Different Stages of COVID-19-a Prospective Observational Study.
Objective:
The risk of thrombotic complications in critical COVID-19 patients remains extremely high, and multicenter trials failed to prove the survival benefit of escalated doses of low molecular weight heparins (LMWH) in this group. The aim of this study was to develop a pharmacokinetic model of LMWH (nadroparin calcium) according to different stages of COVID-19 severity.
Read more
Design:
The investigators performed a prospective observational study.
Patients:
Blood samples were obtained from 43 COVID-19 patients that received nadroparin and were treated with conventional oxygen therapy, mechanical ventilation, and extracorporeal membrane oxygenation.
Setting:
The investigators recorded clinical, biochemical, and hemodynamic variables during 72 hours of treatment. The analyzed data comprised 782 serum nadroparin concentrations and 219 anti-factor Xa levels. The investigators conducted population nonlinear mixed-effects modeling (NONMEM) and performed Monte Carlo simulations of the probability of target attainment (PTA) for reaching 0.2-0.5 IU/ml anti-Xa levels in study groups.
Interventions: None.
Measurements and Main Results:
The investigators successfully developed a one-compartment model to describe the population pharmacokinetics of nadroparin in different stages of COVID-19.
Conclusions:
Different nadroparin dosing is required for patients undergoing mechanical ventilation and ECMO to achieve the same targets as those for non-critically ill patients.
- Conditions
- Thrombosis, Nadroparin, COVID-19, Mechanical Ventilation, Anticoagulants and Bleeding Disorders
- Being tested
- Nadroparin
- Medical subject headings
- Thrombosis, COVID-19, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NadroparinDrug
Subcutaneous injection of nadroparin according to the ICU guidelines for thromboprophylaxis in ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| conventional oxygen therapy | Patients treated with conventional oxygen in Infectious Diseases Ward. Receives: Drug: Nadroparin | |
| mechanical ventilation | Patients who are mechanically ventilated and treated in ICU. Receives: Drug: Nadroparin | |
| mechanical ventilation and ECMO | Patients who are mechanically ventilated and on ECMO treated in ICU. Receives: Drug: Nadroparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nadroparin concentration in blood measurement
Sequential measurement every 6 hours
Measured: 6 hours
Change in anti-Xa serum level
Sequential measurement every 12 hours
Measured: 12 hours
Secondary outcomes (3)
Volume of distribution of nadroparin
Measured: 24 hours
Clearance of nadroparin
Measured: 24 hours
Absorption rate of nadroparin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Feb 2021
- Primary completion10 Feb 2022
- Study completion15 Apr 2022
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 ThrombosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Principal investigator, Paweł Piwowarczyk, Medical University of Lublin
- Investigators
- Paweł Piwowarczyk, MD PhD, Principal investigator, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621915
- Sponsor's protocol ID
- KE 0254/23/2021
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piwowarczyk P, Szczukocka M, Cios W, Okunska P, Raszewski G, Borys M, Wiczling P, Czuczwar M. Population Pharmacokinetics and Probability of Target Attainment Analysis of Nadroparin in Different Stages of COVID-19. Clin Pharmacokinet. 2023 Jun;62(6):835-847. doi: 10.1007/s40262-023-01244-4. Epub 2023 Apr 25.
PubMed 37097604
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nadroparin Pharmacokinetics in Different Stages of COVID-19-a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05621915
- Acronym / sponsor ID
- KE 0254/23/2021
- Conditions
- Thrombosis, Nadroparin, COVID-19, Mechanical Ventilation, Anticoagulants and Bleeding Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 18 Nov 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.
Objective:
The risk of thrombotic complications in critical COVID-19 patients remains extremely high, and multicenter trials failed to prove the survival benefit of escalated doses of low molecular weight heparins (LMWH) in this group. The aim of this study was to develop a pharmacokinetic model of LMWH (nadroparin calcium) according to different stages of COVID-19 severity.
Design:
The investigators performed a prospective observational study.
Patients:
Blood samples were obtained from 43 COVID-19 patients that received nadroparin and were treated with conventional oxygen therapy, mechanical ventilation, and extracorporeal membrane oxygenation.
Setting:
The investigators recorded clinical, biochemical, and hemodynamic variables during 72 hours of treatment. The analyzed data comprised 782 serum nadroparin concentrations and 219 anti-factor Xa levels. The investigators conducted population nonlinear mixed-effects modeling (NONMEM) and performed Monte Carlo simulations of the probability of target attainment (PTA) for reaching 0.2-0.5 IU/ml anti-Xa levels in study groups.
Interventions: None.
Measurements and Main Results:
The investigators successfully developed a one-compartment model to describe the population pharmacokinetics of nadroparin in different stages of COVID-19.
Conclusions:
Different nadroparin dosing is required for patients undergoing mechanical ventilation and ECMO to achieve the same targets as those for non-critically ill patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional oxygen therapy | – | Drug: NadroparinPatients treated with conventional oxygen in Infectious Diseases Ward. |
| mechanical ventilation | – | Drug: NadroparinPatients who are mechanically ventilated and treated in ICU. |
| mechanical ventilation and ECMO | – | Drug: NadroparinPatients who are mechanically ventilated and on ECMO treated in ICU. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- First group (Group 1) consisted of 14 patients treated with conventional oxygen therapy only in the infectious diseases department. The second group (Group 2) consisted of 14 mechanically ventilated patients treated in the ICU, and the third group (Group 3) was formed by 15 patients supported with extracorporeal membrane oxygenation (ECMO) and mechanically ventilated in the ICU. The investigators used surviving sepsis campaign guidelines for COVID-19 for the escalation of treatment in the study population.
Key inclusion criteria (1 listed)
- Patients treated in the Department of Anesthesiology and Intensive Care and the Department of Infectious Diseases of a tertiary academic hospital with confirmed SARS-CoV-2 infection with a real-time reverse transcription polymerase chain reaction (RT-PCR) or an antigen test.
Key exclusion criteria (1 listed)
- Coagulation disorders at the start of the therapy.
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 |
|---|---|---|
| NadroparinSubcutaneous injection of nadroparin according to the ICU guidelines for thromboprophylaxis in ICU patients. | Drug | conventional oxygen therapy, mechanical ventilation, mechanical ventilation and ECMO |
Primary outcome
Change in nadroparin concentration in blood measurement
Time frame: 6 hours
Sequential measurement every 6 hours
Change in anti-Xa serum level
Time frame: 12 hours
Sequential measurement every 12 hours
3 secondary outcomes
Volume of distribution of nadroparin
Time frame: 24 hours
Clearance of nadroparin
Time frame: 24 hours
Absorption rate of nadroparin
Time frame: 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 18 Nov 2022.
- Derived from this study: PubMed 37097604Piwowarczyk P, Szczukocka M, Cios W, Okunska P, Raszewski G, Borys M, Wiczling P, Czuczwar M. Population Pharmacokinetics and Probability of Target Attainment Analysis of Nadroparin in Different Stages of COVID-19. Clin Pharmacokinet. 2023 Jun;62(6):835-847. doi: 10.1007/s40262-023-01244-4. Epub 2023 Apr 25.
- 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.
Paweł Piwowarczyk, MD PhD principal investigator
Medical University of Lublin
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 Thrombosis and Nadroparin, run by Medical University of Lublin 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 1 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 18 Nov 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 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?
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?
Change in nadroparin concentration in blood measurement (time frame: 6 hours). The study lists 2 primary outcomes in all. 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 NCT05621915, 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 18 Nov 2022.