Practice Variation on Antithrombotics in COVID-19

Completed

• Conditions: Thrombosis; COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Pneumonia; Severe Acute Respiratory Syndrome (SARS) Pneumonia

• Registration Number: NCT04998799
• Lead Sponsor: NMC Specialty Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2021-08-08
• Study First Posted: 2021-08-10
• Study Start: 2021-10-01
• Primary Completion: 2021-10-30
• Status Verified: 2021-11
• Study Completion: 2021-11-10
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Choice, dose, and indication of antithrombotics for management of COVID-19.	two weeks	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

Trial Locations

Locations (1)

Reliance Hospital; 🇮🇳 Mumbai, Mumbai, Mahrastra, India