Covid19AntiXCOVIDNCT05256524
Is Anti-Factor Xa Associated With Outcome in Patients With Critical COVID-19 on Low-Molecular-Weight Heparin?
An observational study of Covid19 and Thromboembolism, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Patients with critical COVID-19 are hyper-coagulable and optimal thromboprophylaxis treatment differs with stage and severity. The most commonly used drug for thromboprophylaxis in the intensive care unit (ICU) is low-molecular-weight heparin (LMWH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Thromboembolism, Bleeding
- What is being tested?
- The effect of LMWH and Monitoring frequency of aFXa-levels
- How many people
- 1,520 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 29 Aug 2021
- 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 patients with critical COVID-19 and respiratory failure admitted to ICU at Södersjukhuset, Karolinska Sjukhuset and Skånes Universitetssjukhus, in Sweden, between March 1 2020 and May 31 2021 are eligible. Patients will be included on their first admission to the ICU if admitted more than once. First admission can be replaced by the second one if the first one is considered very short/insignificant compared to the second one. If a patient is transferred from one ICU to another this will be considered the same admission but they will be grouped according to their initial ICU.
Who may be able to join
- Patients with critical COVID-19 and respiratory failure
- Positive SARS-CoV-2 test
- LMWH-effect monitored by aFXa, as a trough or peak value, after at least four doses at a twice daily regime
Who cannot join
- Diagnosed thromboembolism or major bleeding during their COVID-illness prior to ICU-admission or as a reason or contributing factor for the ICU-admission.
- Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Anti-Factor Xa Associated With Mortality, Thromboembolism and Bleeding in Patients With Critical COVID-19 Patients on Low-Molecular-Weight Heparin?
Patients with critical COVID-19 are hyper-coagulable and optimal thromboprophylaxis treatment differs with stage and severity. The most commonly used drug for thromboprophylaxis in the intensive care unit (ICU) is low-molecular-weight heparin (LMWH). In contrast to unfractionated heparins, the effects of LMWH usually do not require monitoring. Exceptions from this are when elimination of LMWH is impaired, extremes in age and weight, to identify deviations from predicted pharmacokinetics, and if there is an unexpected clinical response. The unexpected high incidence of thromboembolic complications among patients with critical COVID-19 compared to critically ill non-COVID-19 patients could motivate monitoring. The activity of LMWH is monitored by quantifying the presence of anti-Factor Xa (aFXa). The aim of this study is to investigate if the level and the monitoring frequency of aFXa is associated to mortality, thrombosis and bleeding in patients with critical COVID-19 treated with LMWH and therefore could be used as a potential tool to guide LMWH-treatment.
- Conditions
- Covid19, Thromboembolism, Bleeding
- Being tested
- The effect of LMWH, Monitoring frequency of aFXa-levels
- Keywords
- Low-molecular-weight Heparin, Anti-Factor Xa, Critical Care
- Medical subject headings
- COVID-19, Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of LMWHDrug
Quantified by aFXa-levels
Monitoring frequency of aFXa-levelsDiagnostic test
The frequency of aFXa-levels being sampled, analysed and integrated as a possible part of the basis for clinical decisionmaking
| Study group | Role | What they receive |
|---|---|---|
| Patients with critical COVID-19 responding to LMWH treatment | Responders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH. Receives: Drug: The effect of LMWH; Diagnostic Test: Monitoring frequency of aFXa-levels | |
| Patients with critical COVID-19 not responding to LMWH treatment | Non-responders are defined as patients who do not achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH. Receives: Drug: The effect of LMWH; Diagnostic Test: Monitoring frequency of aFXa-levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
90-day mortality
Measured: 90 days from ICU admission
Secondary outcomes (2)
Thromboembolic events
Thromboembolic events are defined as the cumulative proportion of pulmonary embolism (PE), ischemic stroke and deep venous thrombosis (DVT).
PE must be verified by computed tomography or by clinical suspicion as cause of deterioration combined with findings of acute strain of the right heart on echocardiography. Ischemic stroke must be verified by computed tomography. DVT must by verified by ultrasound or by computed tomography.
Measured: 28 days from ICU-admission
Bleeding events
Bleeding events are categorized according to the World health organization (WHO) bleeding scale: 1) Petechiae, tissue hematoma, oropharyngeal bleeding, 2) Mild blood loss, hematemesis, macroscopic hematuria, hemoptysis, joint bleeding, 3) Gross blood loss requiring red blood cell transfusion and/or hemodynamic instability, 4) Debilitating blood loss, severe hemodynamic instability, fatal bleeding, or central nervous system bleeding.
Measured: 28 days 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 posted25 Feb 2022
- Study start1 Mar 2020
- Primary completion31 May 2021
- Study completion29 Aug 2021
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 Covid19Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Retrospective
- Enrolment
- 1,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Sandra Jonmarker, Karolinska Institutet
- Investigators
- Sandra Jonmarker, MD, Principal investigator, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256524
- Sponsor's protocol ID
- AntiFactorXa in Covid-19
- Acronym
- AntiXCOVID
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonmarker S, Litorell J, Alarcon F, Al-Abani K, Bjorkman S, Farm M, Grip J, Soderberg M, Hollenberg J, Wahlin RR, Kander T, Rimling L, Martensson J, Joelsson-Alm E, Dahlberg M, Cronhjort M. A retrospective multicenter cohort study of the association between anti-Factor Xa values and death, thromboembolism, and bleeding in patients with critical COVID-19. Thromb J. 2023 Oct 2;21(1):101. doi: 10.1186/s12959-023-00541-z.
PubMed 37784131
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Anti-Factor Xa Associated With Mortality, Thromboembolism and Bleeding in Patients With Critical COVID-19 Patients on Low-Molecular-Weight Heparin?
- ClinicalTrials.gov ID
- NCT05256524
- Acronym / sponsor ID
- AntiXCOVID / AntiFactorXa in Covid-19
- Conditions
- Covid19, Thromboembolism, Bleeding
- Keywords
- Low-molecular-weight Heparin, Anti-Factor Xa, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,520 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 25 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.
Patients with critical COVID-19 are hyper-coagulable and optimal thromboprophylaxis treatment differs with stage and severity. The most commonly used drug for thromboprophylaxis in the intensive care unit (ICU) is low-molecular-weight heparin (LMWH). In contrast to unfractionated heparins, the effects of LMWH usually do not require monitoring. Exceptions from this are when elimination of LMWH is impaired, extremes in age and weight, to identify deviations from predicted pharmacokinetics, and if there is an unexpected clinical response. The unexpected high incidence of thromboembolic complications among patients with critical COVID-19 compared to critically ill non-COVID-19 patients could motivate monitoring. The activity of LMWH is monitored by quantifying the presence of anti-Factor Xa (aFXa). The aim of this study is to investigate if the level and the monitoring frequency of aFXa is associated to mortality, thrombosis and bleeding in patients with critical COVID-19 treated with LMWH and therefore could be used as a potential tool to guide LMWH-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with critical COVID-19 responding to LMWH treatment | – | Drug: The effect of LMWH, Diagnostic Test: Monitoring frequency of aFXa-levelsResponders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH. |
| Patients with critical COVID-19 not responding to LMWH treatment | – | Drug: The effect of LMWH, Diagnostic Test: Monitoring frequency of aFXa-levelsNon-responders are defined as patients who do not achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with critical COVID-19 and respiratory failure admitted to ICU at Södersjukhuset, Karolinska Sjukhuset and Skånes Universitetssjukhus, in Sweden, between March 1 2020 and May 31 2021 are eligible. Patients will be included on their first admission to the ICU if admitted more than once. First admission can be replaced by the second one if the first one is considered very short/insignificant compared to the second one. If a patient is transferred from one ICU to another this will be considered the same admission but they will be grouped according to their initial ICU.
Key inclusion criteria (3 listed)
- Patients with critical COVID-19 and respiratory failure
- Positive SARS-CoV-2 test
- LMWH-effect monitored by aFXa, as a trough or peak value, after at least four doses at a twice daily regime
Key exclusion criteria (2 listed)
- Diagnosed thromboembolism or major bleeding during their COVID-illness prior to ICU-admission or as a reason or contributing factor for the ICU-admission.
- Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible
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 |
|---|---|---|
| The effect of LMWHQuantified by aFXa-levels | Drug | Patients with critical COVID-19 not responding to LMWH treatment, Patients with critical COVID-19 responding to LMWH treatment |
| Monitoring frequency of aFXa-levelsThe frequency of aFXa-levels being sampled, analysed and integrated as a possible part of the basis for clinical decisionmaking | Diagnostic test | Patients with critical COVID-19 not responding to LMWH treatment, Patients with critical COVID-19 responding to LMWH treatment |
Primary outcome
Mortality
Time frame: 90 days from ICU admission
90-day mortality
2 secondary outcomes
Thromboembolic events
Time frame: 28 days from ICU-admission
Bleeding events
Time frame: 28 days from ICU-admission
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 25 Feb 2022.
- Derived from this study: PubMed 37784131Jonmarker S, Litorell J, Alarcon F, Al-Abani K, Bjorkman S, Farm M, Grip J, Soderberg M, Hollenberg J, Wahlin RR, Kander T, Rimling L, Martensson J, Joelsson-Alm E, Dahlberg M, Cronhjort M. A retrospective multicenter cohort study of the association between anti-Factor Xa values and death, thromboembolism, and bleeding in patients with critical COVID-19. Thromb J. 2023 Oct 2;21(1):101. doi: 10.1186/s12959-023-00541-z.
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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.
Sandra Jonmarker, MD principal investigator
Stockholm South General Hospital
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 Covid19 and Thromboembolism, run by Karolinska Institutet at 1 site in Sweden.
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 2 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 25 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 Sweden. 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?
Mortality (time frame: 90 days from ICU admission). 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 NCT05256524, 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 25 Feb 2022.