To establish a point prevalence of asymptomatic proximal lower extremity DVT in patients admitted to the ward with COVID-19.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Pulmonary vascular disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Point prevalence of asymptomatic proximal lower extremity DVT
Secondary outcome
Parameters:
* Symptoms of lower extremity DVT (presence and duration):
o Leg swelling
o Leg pain
o Redness
* Signs of lower extremity DVT:
o Swelling of lower or upper leg as compared to the other leg
o Dilated superficial veins
o Tenderness
* Clinical course of COVID-19:
o Date of first symptoms
o Date of hospital admission
o Date of ICU admission and discharge (if applicable)
* Laboratory results (if available):
o PCR for SARS-CoV-2 (date)
o Prothrombin time, maximum during course of COVID-19 (date), latest
(date)
o Activated partial thromboplastin time, maximum during course of
COVID-19 (date), latest (date)
o D-dimer, maximum during course of COVID-19 (date), latest (date)
o Fibrinogen, minimum during course of COVID-19 (date), latest (date)
o Thrombocytes, minimum during course of COVID-19 (date), latest (date)
o C-reactive protein, maximum during course of COVID-19 (date), latest
(date)
o Lymphocyte count, minimum during course of COVID-19 (date), latest
(date)
* Results of compression ultrasonography:
o Date
o Presence of thrombus in common femoral vein in 3 locations, femoral
vein in 1 location, and popliteal vein of both legs
* Miscellaneous data pertaining to venous thromboembolism:
o Previous venous thromboembolism (date)
o Use of anticoagulants (type, dose)
Endpoints:
* Point prevalence of symptomatic proximal lower extremity DVT
* Relationship between the presence of DVT and clinical, hematological en
biochemical features
Background summary
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, is associated
with coagulopathy and disseminated intravascular coagulation (REF 1,2). This
may result in pulmonary embolism, especially late in the course of the illness,
even despite the administration of thromboprophylaxis (REF 3).
It is unknown whether these emboli originate from asymptomatic lower extremity
deep vein thrombosis (DVT). Detection of DVT in COVID-19 patients admitted to
the ward before embolization to the lungs will result in treatment with
therapeutic dose anticoagulants, which may prevent subsequent pulmonary
embolism and resulting clinical deterioration in a patient group that is
already suffering from respiratory insufficiency.
Study objective
To establish a point prevalence of asymptomatic proximal lower extremity DVT in
patients admitted to the ward with COVID-19.
Study design
Observational study
Study burden and risks
Participants will be asked a small number of questions related to symptoms of
lower extremity DVT, will undergo physical examination of both legs for signs
of DVT and will subsequently be examined for the presence of lower extremity
DVT by compression ultrasonography once. Compression ultrasonography is a
routine investigation that is not harmful or associated with complications.
Patients who do have DVT may experience some slight pain at the site of
compression, but for most patients, even those who have DVT, the examination is
painless. The result of the ultrasonography will be reported to the attending
physician.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
* * 18 years of age
* Admitted to a non-ICU ward
* PCR for SARS-CoV-2 positive on any sample OR diagnosed with COVID-19 on the
basis of clinical, hematological, biochemical and radiological features with
sufficient certainty to admit to a COVID-19 ward
Exclusion criteria
* Failure to give informed consent
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73930.058.20 |