Practice Variation on Antithrombotics in COVID-19

Thrombosis Clinical Trial

Official title:

Current Practices on Antithrombotic Therapy in Hospitalised and Discharged Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04998799
• Other study ID #: ATCOVIDIndia
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: November 10, 2021

Study information

• Verified date: November 2021
• Source: NMC Specialty Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: November 10, 2021
• Est. primary completion date: October 30, 2021
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• COVID-19 Pneumonia
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome (SARS) Pneumonia
• Syndrome
• Thrombosis

Intervention

Behavioral:
• Current clinical practices of participating physicians
Current clinical practice of participating physicians on management of antithrombotics for COVID-19 during hospitalisation and post-discharge

Locations

Country	Name	City	State
India	Reliance Hospital	Mumbai	Mumbai, Mahrastra

Sponsors (1)

Lead Sponsor	Collaborator
NMC Specialty Hospital

Country where clinical trial is conducted

India, 

References & Publications (4)

Chandra A, Chakraborty U, Ghosh S, Dasgupta S. Anticoagulation in COVID-19: current concepts and controversies. Postgrad Med J. 2021 Apr 13. pii: postgradmedj-2021-139923. doi: 10.1136/postgradmedj-2021-139923. [Epub ahead of print] Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choice, dose, and indication of antithrombotics for management of COVID-19.	Through web-based cross-sectional survey will capture the practices of physicians on choice, dose, and indication of antithrombotics for management of COVID-19 during hospitalisation and post-discharge	two weeks