Practice Variation on Antithrombotics in COVID-19

Sponsor
NMC Specialty Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04998799
Collaborator
(none)
435
1
1.3
331

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Current clinical practices of participating physicians

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 Design

Study Type:
Observational
Actual Enrollment :
435 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Current Practices on Antithrombotic Therapy in Hospitalised and Discharged Patients With COVID-19
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Nov 10, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reliance Hospital Mumbai Mumbai, Mahrastra India

Sponsors and Collaborators

  • NMC Specialty Hospital

Investigators

  • Principal Investigator: Prashant Nasa, MD EDICM, NMC Specialty Hospital, Dubai, UAE

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prashant Nasa, Head Critical Care Medicine, NMC Specialty Hospital
ClinicalTrials.gov Identifier:
NCT04998799
Other Study ID Numbers:
  • ATCOVIDIndia
First Posted:
Aug 10, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prashant Nasa, Head Critical Care Medicine, NMC Specialty Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021