Covid19NCT04593654
Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients
An observational study of Covid19 and Thromboembolism, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Thromboembolism
- What is being tested?
- Dose of tinzaparin or dalteparin
- How many people
- 257 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 15 Oct 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 critically ill Covid-19 patients admitted to ICU at Södersjukhuset, Stockholm from1st of March to 15 of July
Who may be able to join
- laboratory confirmed positive test for SARS-CoV-2
- admitted to ICU because of respiratory failure caused by 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 date as ICU admission
- patients without initial thromboprophylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up
The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.
- Conditions
- Covid19, Thromboembolism
- Being tested
- Dose of tinzaparin or dalteparin
- Keywords
- Pulmonary embolism, Anticoagulation, Critical Care, Bleeding, Ischemic stroke
- Medical subject headings
- COVID-19, Thromboembolism, Pulmonary Embolism, Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of tinzaparin or dalteparinDrug
Also called Innohep/Fragmin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
| Study group | Role | What they receive |
|---|---|---|
| low dose thromboprophylaxis | Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin Receives: Drug: Dose of tinzaparin or dalteparin | |
| medium dose thromboprophylaxis | Daily dose of >4500 IU but <175 IU/kg of body weight tinzaparin or >5000 IU but <200 IU/kg of body weight dalteparin Receives: Drug: Dose of tinzaparin or dalteparin | |
| high dose thromboprophylaxis | Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin 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-day mortality
28-day mortality from admission to ICU. Discontinue of ICU-care to palliative care counts as death.
Measured: 28 days from ICU-admission
Secondary outcomes (4)
Incidence of thromboembolic events
Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT) and ischemic stroke. 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.
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
90-day mortality
90-day mortality from admission to ICU.
Measured: 90 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 posted20 Oct 2020
- Study start1 Mar 2020
- Primary completion15 Aug 2020
- Study completion15 Oct 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 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
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Jonmarker, Karolinska Institutet
- Investigators
- Sandra Jonmarker, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593654
- Sponsor's protocol ID
- Thromboprophylaxis COVID-19
- Status last verified
- May 2023
- First submitted
- 16 Oct 2020
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonmarker S, Litorell J, Dahlberg M, Stackelberg O, Everhov AH, Soderberg M, Rubenson-Wahlin R, Gunther M, Martensson J, Hollenberg J, Joelsson-Alm E, Cronhjort M. An observational study of intermediate- or high-dose thromboprophylaxis for critically ill COVID-19 patients. Acta Anaesthesiol Scand. 2022 Mar;66(3):365-374. doi: 10.1111/aas.14013. Epub 2021 Dec 16.
PubMed 34875111
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up
- ClinicalTrials.gov ID
- NCT04593654
- Acronym / sponsor ID
- Thromboprophylaxis COVID-19
- Conditions
- Covid19, Thromboembolism
- Keywords
- Pulmonary embolism, Anticoagulation, Critical Care, Bleeding, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 20 Oct 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 aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose thromboprophylaxis | – | Drug: Dose of tinzaparin or dalteparinDaily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin |
| medium dose thromboprophylaxis | – | Drug: Dose of tinzaparin or dalteparinDaily dose of >4500 IU but <175 IU/kg of body weight tinzaparin or >5000 IU but <200 IU/kg of body weight dalteparin |
| high dose thromboprophylaxis | – | Drug: Dose of tinzaparin or dalteparinDaily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort study of the critically ill Covid-19 patients admitted to ICU at Södersjukhuset, Stockholm from1st of March to 15 of July
Key inclusion criteria (2 listed)
- laboratory confirmed positive test for SARS-CoV-2
- admitted to ICU because of respiratory failure caused by Covid-19
Key exclusion criteria (3 listed)
- patients with treatment for thromboembolic complications at arrival to the ICU
- short ICU length of stay defined as discharged the same date as ICU admission
- patients without initial thromboprophylaxis
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 dalteparinAlso: Innohep/FragminThe patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU | Drug | high dose thromboprophylaxis, low dose thromboprophylaxis, medium dose thromboprophylaxis |
Primary outcome
28-day mortality
Time frame: 28 days from ICU-admission
28-day mortality from admission to ICU. Discontinue of ICU-care to palliative care counts as death.
4 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
90-day mortality
Time frame: 90 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 31 May 2023.
- Derived from this study: PubMed 34875111Jonmarker S, Litorell J, Dahlberg M, Stackelberg O, Everhov AH, Soderberg M, Rubenson-Wahlin R, Gunther M, Martensson J, Hollenberg J, Joelsson-Alm E, Cronhjort M. An observational study of intermediate- or high-dose thromboprophylaxis for critically ill COVID-19 patients. Acta Anaesthesiol Scand. 2022 Mar;66(3):365-374. doi: 10.1111/aas.14013. Epub 2021 Dec 16.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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
Karolinska Institutet
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 2 inclusion and 3 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 31 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 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-day 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 NCT04593654, 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 31 May 2023.