Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK

NCT04405232 | Unknown

• 1 other identifier: 20SM5934
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure \[acute respiratory distress syndrome (ARDS)\] and death is a global threat. On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time \[PT\] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries. Eventually \>50% of people will have become infected and COVID-19 will remain a public health threat in the long term. It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients. In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.

Conditions

COVID; Thrombosis; Bleeding; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• Prevalence and characteristics of coagulation abnormalities and their predictive value for respiratory failure requiring ventilation, multiorgan failure and death in patients presenting with COVID 19 infection

  12 months

Secondary Outcomes (11)

• Incidence of respiratory failure requiring CPAP or mechanical ventilation

  12 months

• Incidence of thrombosis (clinical or radiological diagnosis) including thrombosis within 90 days after hospital admission (hospital associated thrombosis) 4. Incidence of minor bleeding 5. Heparin induced thrombocytopenia 6. Acute coronary syndrome

  12 months

• Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality

  12 months

• Incidence of clinically relevant non-major bleeding

  12 months

• Incidence of Heparin induced thrombocytopenia

  12 months

Interventions

Non-interventional OTHER

Observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\>18 years) admitted hospitals with suspected COVID-19 infection

You may qualify if:

• Adult patients (\>18 years) admitted hospitals with COVID 19 infection (COVID RNA+ +/- radiological change +/- clinical suspicion in absence of RNA)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Deepa Jayakody Arachchillage, FRCPath, MD

  Imperial College London

  STUDY CHAIR

Central Study Contacts

Dr Deepa Jayakody Arachchillage, MRCP, FRCPath, MD

CONTACT

02073518401; d.arachchillage@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: May 25, 2020
• Primary Completion: April 25, 2021
• Study Completion: June 25, 2021
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

GB (1)