Investigating blood clotting changes in patients with COVID-19
| ISRCTN | ISRCTN64783542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64783542 |
| IRAS number | 282457 |
| Secondary identifying numbers | 14937, IRAS 282457 |
- Submission date
- 11/05/2020
- Registration date
- 22/05/2020
- Last edited
- 13/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Infection rates with COVID-19 have risen rapidly across the UK. In patients admitted to hospital with this infection, doctors are noticing unusual abnormalities in blood test results, especially those that measure blood clotting. This is particularly marked in patients with the most severe COVID-19 infection who need to be put on a ventilator in an intensive care unit (ICU). Early studies from China and other European countries also highlighted these clotting abnormalities. It seems that small clots develop in the lungs and sometimes in the kidneys and this can cause these organs to fail. Larger clots can also develop, such as those found in the large blood vessels of the lung (pulmonary emboli, PE) and legs (deep vein thrombosis, DVT). The pattern of clots seen with COVID-19 infection is highly unusual and needs further investigation.
The researchers would like to study the changes to clotting tests (and other blood tests) in all patients admitted to hospital with COVID-19, and to compare the test results seen in patients who require intensive care treatment to those with milder illness. They are particularly interested in whether patients with COVID-19 infection have a higher than normal risk of developing blood clots (both large and small types of clot). The results will be used to understand whether basic blood tests can predict the likelihood that a patient will require intensive care or that they will develop small clots and/or large clots. The tests also might predict the likelihood that a patient with COVID-19 will develop a blood clot while in hospital or after being sent home and whether treatments that have been given as routine care are associated with a reduced risk of clots. Overall, the researchers aim to use these results to understand whether there should be new clot prevention strategies (e.g. higher doses of clot prevention treatments) for all or some of patients with COVID-19.
Who can participate?
Adults admitted to Oxford hospitals with COVID-19
What does the study involve?
This is an observational study, which means that all participants will receive treatment and care as usual. Additional information will be collected on blood clotting and whether participants experience problems related to blood clots while in hospital and in the 90 days after they have been discharged from hospital.
What are the possible benefits and risks of participating?
All participants will receive treatment and care as usual. There are no additional risks of participating.
Where is the study run from?
Oxford University Hospitals NHS Trust
When is the study starting and how long is it expected to run for?
March 2020 to November 2020
Who is funding the study?
The investigators are funding the study.
Who is the main contact?
Dr Nicola Curry, haemophilia.reception@ouh.nhs.uk
Contact information
Scientific
Oxford Haemophilia & Thrombosis Centre
Churchill Hospital
Old Rd
Headington
Oxford
OX3 7LE
United Kingdom
 ORCID ID |
0000-0002-3849-0688 |
|---|---|
| Phone | +44 (0)1865 225316 |
| haemophilia.reception@ouh.nhs.uk |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available. |
| Scientific title | An observational study to evaluate the haematological changes caused by COVID-19 and their association with thrombotic clinical outcomes |
| Study hypothesis | To describe the prevalence and longitudinal changes to coagulation, platelet and haematological parameters in patients with COVID-19 who present for emergency assessment and may require admission to adult critical and other wards and their relationship to routine blood tests. |
| Ethics approval(s) | Approved 06/05/2020, London - London Bridge Research Ethics Committee (Skipton House, 80 London Road, London SE1 6LH; +44 (0)207 104 8029; londonbridge.rec@hra.nhs.uk), ref: 20/HRA/2304 |
| Condition | Thrombosis in patients with COVID-19 (SARS-CoV-2 infection) |
| Intervention | This observational study will collate data on the longitudinal changes seen in clotting test results and correlate these with clinical thrombotic outcomes. It will focus on the rates of venous and arterial thrombosis seen during in-patient stays and will also collect data around venous thrombosis occurring in the 90 days following patient discharge. These data will provide high quality data around the incidence of thrombosis in this patient group and will inform practice change for VTE prevention. |
| Intervention type | Other |
| Primary outcome measure | 1. Coagulation parameters (PT, aPTT, fibrinogen, D-dimer) measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 2. Blood clotting capability measured by thromboelastography (TEG) using a TEG 5000 machine in whole blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 3. Full blood count (FBC) results (platelet count, haemoglobin, white cell count [WCC] and differential) measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 4. Presence of venous thrombosis defined as radiological confirmed evidence of DVT by compression ultrasound or PE by CT pulmonary angiogram (CTPA) or ventilation/perfusion (VQ) scan from date of admission to 90 days following discharge 5. Presence of arterial thrombosis defined as ECG evidence of a myocardial infarction or CT/MRI evidence of an ischaemic stroke during hospital admission |
| Secondary outcome measures | 1. Aspartate transaminase (AST) measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 2. Ferritin measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 3. Troponin measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 4. C-reactive protein (CRP) measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 5. Bilirubin measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 6. Lactate dehydrogenase (LDH) measured using standard hospital laboratory methods in blood taken on days 1, 2, 3, 7, 14, 21 and 28 during hospital stay 7. Co-morbid conditions assessed using patient electronic medical records from admission data 8. Transfusion need assessed using patient electronic medical records during the in-patient stay 9. ISTH bleeding score assessed using using patient electronic medical records during the in-patient stay 10. Presence of multiple organ failure (MOF) assessed using using patient electronic medical records during the in-patient stay 11. Presence of acute respiratory distress syndrome (ARDS) assessed using using patient electronic medical records during the in-patient stay 12. Presence of acute kidney injury (AKI) assessed using using patient electronic medical records during the in-patient stay 13. Organ failure assessed using sequential organ failure assessment (SOFA) score during the in-patient stay 14. Mortality assessed using patient electronic medical records during the in-patient stay 15. VTE assessed using patient electronic medical records and the hospital acquired thrombosis alert system, already in place for recording this data, up to 90 days post-hospital discharge |
| Overall study start date | 01/03/2020 |
| Overall study end date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | All adult patients admitted to Oxford hospitals between the dates 1st March 2020 and 31st August 2020 with COVID-19 infection |
| Total final enrolment | 303 |
| Participant inclusion criteria | 1. Adult (aged 18 years or older) 2. Admitted to Oxford University Hospitals NHS Foundation Trust with confirmed or high clinical suspicion of COVID-19 |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/03/2020 |
| Recruitment end date | 31/08/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford
OX3 9DU
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development
Joint Research Office
Second Floor
OUH Cowley
Unipart House
Garsington Road
Oxford
OX4 2PG
England
United Kingdom
| Phone | +44 (0)1865 572970 |
|---|---|
| ouh.sponsorship@ouh.nhs.uk | |
| Website | http://www.ouh.nhs.uk/ |
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authorship for any publications arising from this study will follow the rules set out by the International Committee of Medical Journal Editors definitions of Authorship and Contributorship, http://www.icmje.org/ethical_1author.html. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/12/2020 | 13/07/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/07/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
16/03/2021: Internal review.
11/05/2020: Trial's existence confirmed by Oxford University Hospitals NHS Foundation Trust.
