Investigating blood clotting changes in patients with COVID-19

An observational study to evaluate the haematological changes caused by COVID-19 and their association with thrombotic clinical outcomes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN64783542

Enrollment

1000

Registered

2020-05-22

Start date

2020-03-01

Completion date

Unknown

Last updated

2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis in patients with COVID-19 (SARS-CoV-2 infection) Circulatory System

Interventions

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 art

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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 p	—

Measure

Time frame

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 p

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026