COVID-19NCT05224388
Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels.
An observational study of COVID-19 and Deep Vein Thrombosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To see whether our increased dosing regimen of unfractionated heparin (UF) and low molecular weight heparin (LMWH) in COVID-19 patients was effective at preventing thrombo-embolic complications. We did regular anti-Xa tests to optimise the dose of our thromboprophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Deep Vein Thrombosis, Anticoagulants and Bleeding Disorders
- What is being tested?
- Enoxaparin and Heparin
- How many people
- 813 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 15 Sep 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: COVID-19 patients and other critical ill patients, during their stay in the intensive care unit of the Ghent University Hospital.
Who may be able to join
- 18 years or older
- Hospitalisation required
- ICU admission
Who cannot join
- Coagulopathies prior to COVID 19 infection (known thromboembolism in the last 6 months i.e. deep venous thrombosis, pulmonary embolism, …)
- Therapeutic anticoagulation on moment of ICU admission
- Major trauma
- Major bleeding
- Cerebro vascular accident or neuro trauma in the last month
Trial locations and contacts
1 site in 1 country.
About this study
To see whether our increased dosing regimen of unfractionated heparin (UF) and low molecular weight heparin (LMWH) in COVID-19 patients was effective at preventing thrombo-embolic complications. We did regular anti-Xa tests to optimise the dose of our thromboprophylaxis. Furthermore, we want to examine the time it takes to reach adequate anti-Xa levels, to determine additional risk factors and do a subgroup analysis. Lastly, we will study if there are possible complications of our thromboprophylactic therapy.
Read the detailed description
COVID-19 took the world by storm with its fast spread, high number of infected patients and its potential to range from mild illness to very severe respiratory distress. This pandemic is currently the focus of a lot of research, however there are still a lot of unknowns regarding COVID-19. Current literature shows that COVID-19 patients have an increased risk for thrombo-embolic events which is why patients at the Ghent university hospital get increased dose of thrombo-prophylactic therapy. Patients were also screened for presence of deep venous thrombosis using ultrasound.
Anti-Xa is a test in which the we determine the activity of the antithrombine-heparine complex on factor Xa. Using this test allowed us to measure the effect of our UF of LWMH and adjust the dose if needed.
At this moment It is still unclear how high the prevalence of thromboembolic events in this group of patients is and whether our thromboprophylaxic therapy prevents this. We also looked into the time it took for anti-Xa to reach adequate levels in our dosing regimen. Furthermore, current risk factors for thromboembolic complications in COVID-19 patients are still unclear. We compared the results of the COVID-19 patients to a group of critical ill patients without COVID-19.
- Being tested
- Enoxaparin, Heparin
- Medical subject headings
- COVID-19, Venous Thrombosis, Hemostatic Disorders, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Clexane
Use of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen
HeparinDrug
Use of heparin in either prophylactic dose regimen or therapeutic dose regimen
| Study group | Role | What they receive |
|---|---|---|
| Critically ill, prophylactic dose regimen | Prophylaxis of deep vein trombosis in critically ill patients Receives: Drug: Enoxaparin; Drug: Heparin | |
| Critically ill, therapeutic dose regimen | Therapeutic anticoagulation for tromboembolic pathology in critically ill patients Receives: Drug: Enoxaparin; Drug: Heparin | |
| Covid, prophylactic dose regimen | Prophylaxis of deep vein trombosis in Covid patients Receives: Drug: Enoxaparin; Drug: Heparin | |
| Covid, therapeutic dose regimen | Therapeutic anticoagulation for tromboembolic pathology in Covid patients Receives: Drug: Enoxaparin; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate dose regimen of UFH en LMWH for critically ill patients and Covid-19 patients in: - preventing thrombo-embolic complications - time to reach adequate prophylactic antiXa range
36 hours after start of the intervention drug (enoxaparin or heparin) the antiXa level is measured
Measured: 36 hours
Secondary outcomes (2)
Possible risk factors for thrombo-embolic complications in COVID-19 patients
Risk factors are minor bleeding, major bleeding
Measured: Time of discharge or death
Safety of increased dose of thromboprophylaxis in Covid-19 patients
Special consideration of minor or major bleeding
Measured: Time of discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jan 2020
- Primary completion31 Aug 2021
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harlinde Peperstraete, MD, Study chair, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224388
- Sponsor's protocol ID
- BC-07991
- Status last verified
- May 2023
- First submitted
- 3 Feb 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels.
- ClinicalTrials.gov ID
- NCT05224388
- Acronym / sponsor ID
- BC-07991
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 813 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 4 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.
To see whether our increased dosing regimen of unfractionated heparin (UF) and low molecular weight heparin (LMWH) in COVID-19 patients was effective at preventing thrombo-embolic complications. We did regular anti-Xa tests to optimise the dose of our thromboprophylaxis. Furthermore, we want to examine the time it takes to reach adequate anti-Xa levels, to determine additional risk factors and do a subgroup analysis. Lastly, we will study if there are possible complications of our thromboprophylactic therapy.
Detailed description
COVID-19 took the world by storm with its fast spread, high number of infected patients and its potential to range from mild illness to very severe respiratory distress. This pandemic is currently the focus of a lot of research, however there are still a lot of unknowns regarding COVID-19. Current literature shows that COVID-19 patients have an increased risk for thrombo-embolic events which is why patients at the Ghent university hospital get increased dose of thrombo-prophylactic therapy. Patients were also screened for presence of deep venous thrombosis using ultrasound.
Anti-Xa is a test in which the we determine the activity of the antithrombine-heparine complex on factor Xa. Using this test allowed us to measure the effect of our UF of LWMH and adjust the dose if needed.
At this moment It is still unclear how high the prevalence of thromboembolic events in this group of patients is and whether our thromboprophylaxic therapy prevents this. We also looked into the time it took for anti-Xa to reach adequate levels in our dosing regimen. Furthermore, current risk factors for thromboembolic complications in COVID-19 patients are still unclear. We compared the results of the COVID-19 patients to a group of critical ill patients without COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Critically ill, prophylactic dose regimen | – | Drug: Enoxaparin, Drug: HeparinProphylaxis of deep vein trombosis in critically ill patients |
| Critically ill, therapeutic dose regimen | – | Drug: Enoxaparin, Drug: HeparinTherapeutic anticoagulation for tromboembolic pathology in critically ill patients |
| Covid, prophylactic dose regimen | – | Drug: Enoxaparin, Drug: HeparinProphylaxis of deep vein trombosis in Covid patients |
| Covid, therapeutic dose regimen | – | Drug: Enoxaparin, Drug: HeparinTherapeutic anticoagulation for tromboembolic pathology in Covid patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients and other critical ill patients, during their stay in the intensive care unit of the Ghent University Hospital.
Key inclusion criteria (3 listed)
- 18 years or older
- Hospitalisation required
- ICU admission
Key exclusion criteria (5 listed)
- Coagulopathies prior to COVID 19 infection (known thromboembolism in the last 6 months i.e. deep venous thrombosis, pulmonary embolism, …)
- Therapeutic anticoagulation on moment of ICU admission
- Major trauma
- Major bleeding
- Cerebro vascular accident or neuro trauma in the last month
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 |
|---|---|---|
| EnoxaparinAlso: ClexaneUse of enoxaparin in either prophylactic dose regimen or therapeutic dose regimen | Drug | Covid, prophylactic dose regimen, Covid, therapeutic dose regimen, Critically ill, prophylactic dose regimen, Critically ill, therapeutic dose regimen |
| HeparinUse of heparin in either prophylactic dose regimen or therapeutic dose regimen | Drug | Covid, prophylactic dose regimen, Covid, therapeutic dose regimen, Critically ill, prophylactic dose regimen, Critically ill, therapeutic dose regimen |
Primary outcome
Evaluate dose regimen of UFH en LMWH for critically ill patients and Covid-19 patients in: - preventing thrombo-embolic complications - time to reach adequate prophylactic antiXa range
Time frame: 36 hours
36 hours after start of the intervention drug (enoxaparin or heparin) the antiXa level is measured
2 secondary outcomes
Possible risk factors for thrombo-embolic complications in COVID-19 patients
Time frame: Time of discharge or death
Safety of increased dose of thromboprophylaxis in Covid-19 patients
Time frame: Time of discharge or death
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 11 May 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.
Harlinde Peperstraete, MD study chair
University Hospital, Ghent
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 COVID-19 and Deep Vein Thrombosis, run by University Hospital, Ghent at 1 site in Belgium.
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 5 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 11 May 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 Belgium. 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?
Evaluate dose regimen of UFH en LMWH for critically ill patients and Covid-19 patients in: - preventing thrombo-embolic complications - time to reach adequate prophylactic antiXa range (time frame: 36 hours). 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 11 May 2023.