Clinical trial NCT04998799: Practice Variation on Antithrombotics in COVID-19
Official title: Current Practices on Antithrombotic Therapy in Hospitalised and Discharged Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
Thrombosis
COVID-19 Acute Respiratory Distress Syndrome
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Keywords: Anticoagulation in COVID-19
Anticoagulants
SARS-CoV-2
Coronavirus Disease 2019
Management of COVID-19
Lead sponsor: NMC Specialty Hospital
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 435
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians from different specialities like Internal Medicine, Pulmonary Medicine, Anesthesiologists, Critical Care Medicine will be recruited through snowballing sampling. A web-based cross-sectional survey will be circulated among the target population by the investigators through e-mail and social media channels.

Brief summary: Evidence suggests coronavirus disease 2019 (COVID-19) is associated with an increased incidence of thromboembolic manifestations. Various guidelines on managing antithrombotics in COVID-19 either provided conflicting guidance or unclear recommendations for post-discharge thromboprophylaxis.

The investigators aim to collect the current practices in India among physicians on antithrombotic therapy for hospitalised patients with COVID-19 and after discharge from the hospital.

Detailed description: Immune dysregulation plays a crucial role in the development of severe coronavirus disease 2019 (COVID-19). The autopsy of lungs in deceased COVID-19 patients showed micro thrombosis and inflammatory infiltrates similar to acute respiratory distress syndrome (ARDS). Reports of increased incidence of arterial or venous thrombosis with COVID-19 made initial recommendations regarding using higher doses of anticoagulation. The markers of thrombosis like D-dimer, platelet count, fibrinogen are also increased in patients with COVID-19 along with other inflammatory markers. The pathophysiology of coagulopathy of COVID-19 is still under research. It is likely multi-factorial involving Inflammation, hypoxia, endothelial dysfunction, direct viral cytopathic effect, platelets and complement activation, derangement of the renin-angiotensin-aldosterone pathway.

From the inception of the pandemic, the physicians started using various antithrombotic with higher than prophylactic doses to treat the prothrombotic state. In the absence of clear guidance with conflicting evidence, there is considerable variation in the practices of physicians managing COVID-19.

The investigators are planning for a nationwide multicentre cross-sectional survey on understanding participating physicians practices on the choice of different antithrombotics available in India as of August 2021.

The survey will have three sections: 1. Demographics 2. Antithrombotics in hospitalised patients 3. Antithrombotics after discharge from the hospital

The investigators intend to involve 1000 physicians from different specialities with the help of the steering committee.

Eligibility criteria: Inclusion Criteria:

• Physicians involved in the management of adult hospitalised patients with COVID-19 in India

Exclusion Criteria:

* Pediatricians
* Physicians involved in the out-patient management of COVID-19
* Refused to participate

Primary outcomes:
measure: Choice, dose, and indication of antithrombotics for management of COVID-19.
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Reliance Hospital
state: Mumbai, Mahrastra
Study officials:
affiliation: NMC Specialty Hospital, Dubai, UAE
name: Prashant Nasa, MD EDICM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chandra A, Chakraborty U, Ghosh S, Dasgupta S. Anticoagulation in COVID-19: current concepts and controversies. Postgrad Med J. 2022 May;98(1159):395-402. doi: 10.1136/postgradmedj-2021-139923. Epub 2021 Apr 13.
citation: Fontelo P, Bastola MM, Zheng Z, Baik SH. A review of thromboembolic events in hospitalized COVID-19 patients. Thromb J. 2021 Jun 29;19(1):47. doi: 10.1186/s12959-021-00298-3.
citation: Jagiasi B, Nasa P, Chanchalani G, Ahmed A, Ak AK, Sodhi K, Mangal K, Singh MK, Gupta N, Bidkar PU, Tyagi RS, Khanikar RG, Tripathy S, Khanzode S, Subba Reddy K, Saigal S, Sivakumar VA, Javeri Y, Tekwani SS. Variation in therapeutic strategies for the management of severe COVID-19 in India: A nationwide cross-sectional survey. Int J Clin Pract. 2021 Oct;75(10):e14574. doi: 10.1111/ijcp.14574. Epub 2021 Jul 18.
citation: Liu Y, Cai J, Wang C, Jin J, Qu L. A systematic review and meta-analysis of incidence, prognosis, and laboratory indicators of venous thromboembolism in hospitalized patients with coronavirus disease 2019. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1099-1111.e6. doi: 10.1016/j.jvsv.2021.01.012. Epub 2021 Jan 30.