Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04400877 |
|
Recruitment Status :
Recruiting
First Posted : May 26, 2020
Last Update Posted : June 11, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| COVID-19 Venous Thromboembolism Pulmonary Embolism Deep Vein Thrombosis SARS-CoV 2 | Diagnostic Test: Diagnostic examination for venous thromboembolism |
In the current SARS-COV-2 pandemic there is a concern about an increased risk of venous thromboembolism (VTE) concurrent with the infection, including both pulmonary embolism (PE) and deep venous thrombosis (DVT) (Klok et al. 2020; Cui et al. 2020; Helms et al. 2020; Leonard-Lorant et al. 2020; Poissy et al. 2020). International guidelines now recommend prophylactic anticoagulation for all hospitalized patients with a SARS-COV-2 infection in the absence of any contraindication (Thachil et al. 2020). The majority of the studies on VTE in SARS-COV-2 infections have been carried out in the ICU and show prevalence of VTE of between 20 and 30%.(Klok et al. 2020; Cui et al. 2020; Helms et al. 2020). This is a clear increase compared to the less than 10 % prevalence seen in other ICU patients (Muscedere, Heyland, and Cook 2007; Deborah Cook et al. 2005; D. Cook et al. 2000). However, a single center study on consecutive ICU patients with severe sepsis showed a prevalence of VTE of 37% (Kaplan et al. 2015) and another recent publication of patients with severe influenza A/H1N1 infection had a prevalence of VTE of 44% (Obi et al. 2019).
This raises the question whether the increase in VTE seen in recent publications of SARS-COV-2 infections is the result of the specific pathophysiology of the virus itself or the subsequent sepsis with multiorgan failure seen in most complicated and severe cases. The former would have large implications for patients treated outside the ICU and possibly outside hospitals (Thachil et al. 2020).
The aim of this study will be to investigate the prevalence of VTE in a regional healthcare system prior to, and during the SARS-COV-2 pandemic and the differences between ICU, hospitalized and outpatient cohorts.
| Study Type : | Observational |
| Estimated Enrollment : | 12000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic |
| Estimated Study Start Date : | June 8, 2020 |
| Estimated Primary Completion Date : | June 19, 2020 |
| Estimated Study Completion Date : | June 30, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
SARS-CoV-2 pos
Patients who have been tested positive for SARS-CoV-2 virus by either nasopharyngeal swab PCR or antibody testing.
|
Diagnostic Test: Diagnostic examination for venous thromboembolism
Patients who have done a diagnostic examination for suspected VTE (pulmonary embolism och deep venous thrombosis) within the health care system of Region Östergötland. Patients without matching diagnostic examination but with a new diagnosis of pulmonary embolism or deep venous thrombosis during the same time periods will also be taking into account.
Other Names:
|
|
SARS-CoV-2 neg
Patients without symptoms for SARS-CoV-2 infection who haven't been tested for the virus or patients with symptoms who have been tested negative for SARS-CoV-2 virus by either nasopharyngeal swab PCR or antibody testing.
|
Diagnostic Test: Diagnostic examination for venous thromboembolism
Patients who have done a diagnostic examination for suspected VTE (pulmonary embolism och deep venous thrombosis) within the health care system of Region Östergötland. Patients without matching diagnostic examination but with a new diagnosis of pulmonary embolism or deep venous thrombosis during the same time periods will also be taking into account.
Other Names:
|
- Is there an increased prevalence of venous thromboembolism in a regional healthcare system in Sweden during the SARS-CoV-2 pandemic? [ Time Frame: March to May in 2020 ]
- Is a SARS-CoV-2-infection an isolated risk factor for thromboembolism? [ Time Frame: March to May in 2020 ]
- Are there geographic differences in the prevalence of venous thromboembolism within the healthcare system? [ Time Frame: March to May in 2020 ]
- Is venous thromboembolism associated with increased mortality adjusted for relevant comorbidities? [ Time Frame: March to May in 2020 ]
- How long is the time between symptom onset of the SARS-CoV-2-infection and any subsequent venous thromboembolism? [ Time Frame: March to May in 2020 ]
- Is treatment with prophylactic antithrombotic or anticoagulant treatment associated with increased survival? [ Time Frame: March to May in 2020 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
For enrolment, we will consider all patients who have done a diagnostic examination for suspected VTE (pulmonary embolism och deep venous thrombosis) within the health care system of Region Östergötland during March, April and May 2015 through 2020. We will also include all patients with a new diagnosis of pulmonary embolism or deep venous thrombosis during the same time periods.
Region Östergötland/Östergötland County has a population of 465,495 (December 31, 2019).
Inclusion Criteria:
- Any patient that has done a Computer Tomography Angiography of the lungs between 1:st of March and 31:st of May each year from 2015 to 2020
- Any patient that has done a Ultrasound of the legs between 1:st of March and 31:st of May each year from 2015 to 2020
- Any patient with a new diagnosis of pulmonary embolism or deep venous thrombosis between 1:st of March and 31:st of May each year from 2015 to 2020
Exclusion Criteria:
- Incomplete diagnostic examination
- Follow-up examination of know acute VTE
- Primary investigation done outside the healthcare system
- Patient <18 years of age
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400877
| Contact: Daniel Wilhelms, PhD | +461030000 | daniel.wilhelms@liu.se | |
| Contact: Joakim Henricson, PhD | +461030000 | joakim.henricson@regionostergotland.se |
| Sweden | |
| University Hospital Linköping | Recruiting |
| Linköping, Östergötland, Sweden, 58185 | |
| Contact: Daniel Wilhelms, PhD +461030000 daniel.wilhelms@liu.se | |
| Contact: Joakim Henricson, PhD +461030000 joakim.henricson@regionostergotland.se | |
| Principal Investigator: | Jens Wretborn, MD | Emergency Department, University Hospital Linköping, Sweden | |
| Principal Investigator: | Patrik Benjaminsson Nyberg, PhD | Emergency Department, University Hospital Linköping, Sweden | |
| Principal Investigator: | Matthias Jörg, MD | Emergency Department, University Hospital Linköping, Sweden |
Publications:
| Responsible Party: | Daniel Wilhelms, MD, Emergency department head of research, University Hospital, Linkoeping |
| ClinicalTrials.gov Identifier: | NCT04400877 |
| Other Study ID Numbers: |
SE2020-02701 |
| First Posted: | May 26, 2020 Key Record Dates |
| Last Update Posted: | June 11, 2020 |
| Last Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Pulmonary Embolism Thrombosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |