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Practice Variation on Antithrombotics in COVID-19

NCT ID: NCT04998799

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

435 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2021-11-10

Brief Summary

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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

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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.

Conditions

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COVID-19 Pneumonia Thrombosis COVID-19 Acute Respiratory Distress Syndrome Severe Acute Respiratory Syndrome (SARS) Pneumonia

Keywords

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Anticoagulation in COVID-19 Anticoagulants SARS-CoV-2 Coronavirus Disease 2019 Management of COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Current clinical practices of participating physicians

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NMC Specialty Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prashant Nasa

Head Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prashant Nasa, MD EDICM

Role: PRINCIPAL_INVESTIGATOR

NMC Specialty Hospital, Dubai, UAE

Locations

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Reliance Hospital

Mumbai, Mumbai, Mahrastra, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 33850011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34187490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34171154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33529719 (View on PubMed)

Other Identifiers

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ATCOVIDIndia

Identifier Type: -

Identifier Source: org_study_id