Covid-19NCT04412304
Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients
An observational study of Covid-19 and Thromboembolic Events, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid-19, Thromboembolic Events, Bleeding
- What is being tested?
- Dose of Tinzaparin or Dalteparin
- How many people
- 166 participants
- Where
- 1 siteSweden
- Study dates
- 6 Mar 2020to 28 May 2020
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A cohort study of the Covid-19 patients admitted to an ICU at Stockholm South General Hospital from March 6th 2020 to April 30 2020
Who may be able to join
- laboratory confirmed positive test for SARS-CoV-2
- admitted to ICU because of critical illness due to covid-19
Who cannot join
- patients with treatment for thromboembolic complications at arrival to the ICU
- short ICU length of stay defined as discharged the same or the following day as ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden
The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.
- Conditions
- Covid-19, Thromboembolic Events, Bleeding
- Being tested
- Dose of Tinzaparin or Dalteparin
- 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.
Dose of Tinzaparin or DalteparinDrug
The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| thrombose prophylaxis | The dose used to prevent thromboembolic complication in critically ill Receives: Drug: Dose of Tinzaparin or Dalteparin | |
| double thrombose prophylaxis | Double the dose used to prevent thromboembolic complication in critically ill Receives: Drug: Dose of Tinzaparin or Dalteparin | |
| full dose anticoagulant | Dose used to treat thromboembolic event Receives: Drug: Dose of Tinzaparin or Dalteparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-days ICU mortality
28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.
Measured: 28 days from ICU-admission
Secondary outcomes (3)
Incidence of thromboembolic events
Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT), ischemic stroke and other peripheral arterial emboli. PE is defined as PE verified by computer tomography or by findings of acute strain of the right heart on echocardiography combined with a clinical interpretation of the patients deteriorating as a probable PE stated in the medical records. DVT is defined as DVT verified with ultrasound. Ischemic stroke is defined as ischemic stroke verified by computer tomography. Peripheral arterial emboli are defined as peripheral arterial emboli verified by computer tomography.
Measured: 28 days from ICU-admission
Incidence of bleeding events
The event of bleeding will be defined by WHO modified bleeding scale as 1-4.
Measured: 28 days from ICU-admission
ICU-free days alive from ICU-admission.
ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment.
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 posted2 Jun 2020
- Study start6 Mar 2020
- Primary completion30 Apr 2020
- Study completion28 May 2020
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 Covid-19Studies 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christer Svensen, Karolinska Institutet
- Investigators
- Maria Cronhjort, PhD, Principal investigator, Karolinska Institutet, Department of Clinical Science and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412304
- Sponsor's protocol ID
- Anticoagulant therapy Covid-19
- Status last verified
- Jun 2020
- First submitted
- 30 May 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonmarker S, Hollenberg J, Dahlberg M, Stackelberg O, Litorell J, Everhov AH, Jarnbert-Pettersson H, Soderberg M, Grip J, Schandl A, Gunther M, Cronhjort M. Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients. Crit Care. 2020 Nov 23;24(1):653. doi: 10.1186/s13054-020-03375-7.
PubMed 33225952
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden
- ClinicalTrials.gov ID
- NCT04412304
- Acronym / sponsor ID
- Anticoagulant therapy Covid-19
- Conditions
- Covid-19, Thromboembolic Events, Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 2 Jun 2020 (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.
The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| thrombose prophylaxis | – | Drug: Dose of Tinzaparin or DalteparinThe dose used to prevent thromboembolic complication in critically ill |
| double thrombose prophylaxis | – | Drug: Dose of Tinzaparin or DalteparinDouble the dose used to prevent thromboembolic complication in critically ill |
| full dose anticoagulant | – | Drug: Dose of Tinzaparin or DalteparinDose used to treat thromboembolic event |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort study of the Covid-19 patients admitted to an ICU at Stockholm South General Hospital from March 6th 2020 to April 30 2020
Key inclusion criteria (2 listed)
- laboratory confirmed positive test for SARS-CoV-2
- admitted to ICU because of critical illness due to covid-19
Key exclusion criteria (2 listed)
- patients with treatment for thromboembolic complications at arrival to the ICU
- short ICU length of stay defined as discharged the same or the following day as ICU admission
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 |
|---|---|---|
| Dose of Tinzaparin or DalteparinThe patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU. | Drug | double thrombose prophylaxis, full dose anticoagulant, thrombose prophylaxis |
Primary outcome
28-days ICU mortality
Time frame: 28 days from ICU-admission
28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.
3 secondary outcomes
Incidence of thromboembolic events
Time frame: 28 days from ICU-admission
Incidence of bleeding events
Time frame: 28 days from ICU-admission
ICU-free days alive from ICU-admission.
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 22 Jun 2020.
- Derived from this study: PubMed 33225952Jonmarker S, Hollenberg J, Dahlberg M, Stackelberg O, Litorell J, Everhov AH, Jarnbert-Pettersson H, Soderberg M, Grip J, Schandl A, Gunther M, Cronhjort M. Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients. Crit Care. 2020 Nov 23;24(1):653. doi: 10.1186/s13054-020-03375-7.
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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.
Maria Cronhjort, PhD principal investigator
Karolinska Institutet, Department of Clinical Science and Education
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 Thromboembolic Events, 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 2 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 22 Jun 2020. 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?
28-days ICU mortality (time frame: 28 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 NCT04412304, 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 22 Jun 2020.