Venous ThromboembolismGRACENCT06166537
GRACE: Evaluating Compression Stockings in Patients That Require Extended Duration Pharmacological Thromboprophylaxis
A study testing Graduated compression stockings and No Graduated compression stockings in people with Venous Thromboembolism and Surgery, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
Individuals attending the hospital to undergo operations are at risk of developing blood clots in the legs, known as deep vein thrombosis (DVT). A clot in the leg can cause swelling, pain, and other long-term problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Surgery
- What is being tested?
- Graduated compression stockings and No Graduated compression stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,608 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 27 Apr 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age)
- Participants undergoing elective surgery; risk assessed as requiring EDPTP
Who cannot join
- Contraindications to EDPTP or GCS
- Individuals requiring therapeutic anticoagulation e.g., anticoagulation for previous DVT
- Known thrombophilia or thrombogenic disorder
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Francine Heatley, PhD contact
United Kingdom3 sites, 3 recruiting
- Recruiting
North Bristol NHS Trust
Bristol
Anne Pullyblank
- Recruiting
Imperial College Healthcare NHS Trust
London
Alun H Davies, a.h.davies@imperial.ac.uk
- Recruiting
University College London NHS Trust
London
Sujith Konan
About this study
Official title: Graduated Compression Stocking as an Adjunct to Extended Duration Pharmacological Thromboprophylaxis for Venous Thromboembolism Prevention
Individuals attending the hospital to undergo operations are at risk of developing blood clots in the legs, known as deep vein thrombosis (DVT). A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lungs' ability to move oxygen from the air into the blood and may be life-threatening. This is known as pulmonary embolism (PE). DVT and PE are known collectively as venous thromboembolism or VTE.
The importance of preventing VTE in surgical patients is widely recognised, with two main strategies used: thinning the blood with regular injections and/or tablets and wearing elastic stockings to help stop blood from sitting in the leg veins where it can clot.
Read more
Evidence for using elastic stockings to prevent VTE has recently been challenged. Additionally, there is a lack of evidence for the additional benefit of stockings over and above that of blood thinning medications. If stockings were to reduce VTE over and above blood thinning medication, these benefits need to be weighed against the risks and disadvantages of stockings, including discomfort, restricting blood flow to the leg causing blisters and wounds in addition to the cost. If stockings were found not to reduce the risk of clots, they would no longer need to be used in these patients, thus reducing the disadvantages of stockings, and saving the NHS millions of pounds per year.
Certain types of operations (300,000 per year in the UK) are linked with a particularly high risk of VTE, including cancer surgery, surgery in the abdomen and pelvis, and bone (orthopaedic) surgery. In these cases, patients are offered blood thinning medications both during their hospital stay and for a period after they have left the hospital. Furthermore, these patients are offered stockings to wear while in the hospital.
It is not known if, in patients who receive blood thinning medications both in hospital and after discharge, the addition of wearing stockings whilst in hospital reduces their risk of VTE any further.
The purpose of this study is to investigate if it is worthwhile using stockings, in addition to blood thinning medication, to reduce blood clots after surgery. People enrolled in the study will be those at the highest risk of VTE and require an extended period of medication to reduce the risk of a blood clot.
A computer will randomly choose one of the below treatments by chance to make the trial fair:
- Extended duration clot-reducing medicine in addition to stockings B) Extended duration clot-reducing medicine alone
The surgery and all the other medical care will continue as normal. Everyone in the study will get an ultrasound scan at 21 - 35 days after their operation to check if they have developed a blood clot. This is an additional scan, not routinely performed in the NHS, to make sure that all blood clots are detected at an early stage. Participants will receive a phone call at 7, 21-35 and 90 days after their treatment to see if they have developed a blood clot or had any problems with the treatment.
Read the detailed description
Research question: Is it beneficial to provide graduated compression stockings (GCS) in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for surgical patients at highest risk of venous thromboembolism (VTE)? Background: Hospital-acquired thrombosis (HAT) is defined as any VTE within 90 days of hospital admission, encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE). HAT represents a significant cause of preventable mortality, with over 12,000 people dying each year from hospital-associated VTE in the UK, 10-fold higher than the number dying from road traffic accidents.
Previous studies report that the risk of untreated high-risk surgical patients developing HAT is as high as 40-60% in orthopaedic patients and 15-40% in general surgery patients. For these patients at highest risk of VTE, key prevention strategies include extended pharmacological thromboprophylaxis (EDPTP) prescribed beyond hospital discharge and provision of graduated compression stockings (GCS). There is compelling evidence to support the use of pharmacological thromboprophylaxis, however, there is little evidence to support the use of additional GCS alongside causing complications in as many as 5% of patients. The cost of providing GCS equates to a minimum of £31.05 per patient episode, with as many as 270,000 relevant procedures conferring a high-risk of VTE, it could be costing the NHS £8.3 million per annum.
Aims and objectives: The GRACE trial aims to establish whether:-
- patients undergoing surgical procedures requiring EDPTP benefit from additional GCS to prevent VTE
- patients receiving GCS experience an increased rate of adverse events
Methods: Assessor-blinded randomised controlled trial with a non-inferiority comparison. 8,608 participants will be randomised in a 1:1 fashion to one of two thromboprophylaxis strategies:
- EDPTP* in addition to GCS, or
- EDPTP alone *EDPTP includes any anti-thrombotic agent prescribed at a prophylactic dose for prevention of VTE, including low-molecular weight heparin, directly acting oral anticoagulants, or antiplatelet therapy.
Everyone in the study will get an ultrasound scan at 21 - 35 days after their operation to check if they have developed a blood clot. This is an additional scan, not routinely performed in the NHS, to make sure that all blood clots are detected at an early stage. Participants will receive a phone call at 7, 21-35 and 90 days after their treatment to see if they have developed a blood clot or had any problems with the treatment.
- Conditions
- Venous Thromboembolism, Surgery
- Being tested
- Graduated compression stockings, No Graduated compression stockings
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated compression stockingsOther
Also called TED Stockings
Graduated compression stockings are standard care (control)
No Graduated compression stockingsOther
Also called No TED Stockings
No Graduated compression stockings is the intervention
| Study group | Role | What they receive |
|---|---|---|
| EDPTP plus GCS | Other | Control - Extended duration pharmacological thromboprophylaxis (EDPTP) and Graduated compression stockings (GCS). Receives: Other: Graduated compression stockings |
| EDPTP alone | Other | Intervention - Extended duration pharmacological thromboprophylaxis (EDPTP) alone, no stockings Receives: Other: No Graduated compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging-confirmed lower limb Deep Venous Thrombosis with or without symptoms, or Pulmonary Embolism with symptoms.
The number of participants that have a Venous thromboembolism (VTE) event.
Measured: up to 90 days post-surgery
Secondary outcomes (3)
Mortality
The number of participants that die
Measured: up to 90 days post-surgery
Adverse event
The number of participants that experience adverse events related to GSC or EDPTP
Measured: up to 90 days post-surgery
Safety outcomes
The number of participants that experience major bleeding events
Measured: up to 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start27 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessor-blinded randomised controlled trial with a non-inferiority comparison
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8,608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166537
- Sponsor's protocol ID
- 22HH7932
- Acronym
- GRACE
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graduated Compression Stocking as an Adjunct to Extended Duration Pharmacological Thromboprophylaxis for Venous Thromboembolism Prevention
- ClinicalTrials.gov ID
- NCT06166537
- Acronym / sponsor ID
- GRACE / 22HH7932
- Conditions
- Venous Thromboembolism, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,608 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals attending the hospital to undergo operations are at risk of developing blood clots in the legs, known as deep vein thrombosis (DVT). A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lungs' ability to move oxygen from the air into the blood and may be life-threatening. This is known as pulmonary embolism (PE). DVT and PE are known collectively as venous thromboembolism or VTE.
The importance of preventing VTE in surgical patients is widely recognised, with two main strategies used: thinning the blood with regular injections and/or tablets and wearing elastic stockings to help stop blood from sitting in the leg veins where it can clot.
Evidence for using elastic stockings to prevent VTE has recently been challenged. Additionally, there is a lack of evidence for the additional benefit of stockings over and above that of blood thinning medications. If stockings were to reduce VTE over and above blood thinning medication, these benefits need to be weighed against the risks and disadvantages of stockings, including discomfort, restricting blood flow to the leg causing blisters and wounds in addition to the cost. If stockings were found not to reduce the risk of clots, they would no longer need to be used in these patients, thus reducing the disadvantages of stockings, and saving the NHS millions of pounds per year.
Certain types of operations (300,000 per year in the UK) are linked with a particularly high risk of VTE, including cancer surgery, surgery in the abdomen and pelvis, and bone (orthopaedic) surgery. In these cases, patients are offered blood thinning medications both during their hospital stay and for a period after they have left the hospital. Furthermore, these patients are offered stockings to wear while in the hospital.
It is not known if, in patients who receive blood thinning medications both in hospital and after discharge, the addition of wearing stockings whilst in hospital reduces their risk of VTE any further.
The purpose of this study is to investigate if it is worthwhile using stockings, in addition to blood thinning medication, to reduce blood clots after surgery. People enrolled in the study will be those at the highest risk of VTE and require an extended period of medication to reduce the risk of a blood clot.
A computer will randomly choose one of the below treatments by chance to make the trial fair:
- Extended duration clot-reducing medicine in addition to stockings B) Extended duration clot-reducing medicine alone
The surgery and all the other medical care will continue as normal. Everyone in the study will get an ultrasound scan at 21 - 35 days after their operation to check if they have developed a blood clot. This is an additional scan, not routinely performed in the NHS, to make sure that all blood clots are detected at an early stage. Participants will receive a phone call at 7, 21-35 and 90 days after their treatment to see if they have developed a blood clot or had any problems with the treatment.
Detailed description
Research question: Is it beneficial to provide graduated compression stockings (GCS) in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for surgical patients at highest risk of venous thromboembolism (VTE)? Background: Hospital-acquired thrombosis (HAT) is defined as any VTE within 90 days of hospital admission, encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE). HAT represents a significant cause of preventable mortality, with over 12,000 people dying each year from hospital-associated VTE in the UK, 10-fold higher than the number dying from road traffic accidents.
Previous studies report that the risk of untreated high-risk surgical patients developing HAT is as high as 40-60% in orthopaedic patients and 15-40% in general surgery patients. For these patients at highest risk of VTE, key prevention strategies include extended pharmacological thromboprophylaxis (EDPTP) prescribed beyond hospital discharge and provision of graduated compression stockings (GCS). There is compelling evidence to support the use of pharmacological thromboprophylaxis, however, there is little evidence to support the use of additional GCS alongside causing complications in as many as 5% of patients. The cost of providing GCS equates to a minimum of £31.05 per patient episode, with as many as 270,000 relevant procedures conferring a high-risk of VTE, it could be costing the NHS £8.3 million per annum.
Aims and objectives: The GRACE trial aims to establish whether:-
- patients undergoing surgical procedures requiring EDPTP benefit from additional GCS to prevent VTE
- patients receiving GCS experience an increased rate of adverse events
Methods: Assessor-blinded randomised controlled trial with a non-inferiority comparison. 8,608 participants will be randomised in a 1:1 fashion to one of two thromboprophylaxis strategies:
- EDPTP* in addition to GCS, or
- EDPTP alone *EDPTP includes any anti-thrombotic agent prescribed at a prophylactic dose for prevention of VTE, including low-molecular weight heparin, directly acting oral anticoagulants, or antiplatelet therapy.
Everyone in the study will get an ultrasound scan at 21 - 35 days after their operation to check if they have developed a blood clot. This is an additional scan, not routinely performed in the NHS, to make sure that all blood clots are detected at an early stage. Participants will receive a phone call at 7, 21-35 and 90 days after their treatment to see if they have developed a blood clot or had any problems with the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Assessor-blinded randomised controlled trial with a non-inferiority comparison
| Arm | Type | Receives |
|---|---|---|
| EDPTP plus GCS | Other | Other: Graduated compression stockingsControl - Extended duration pharmacological thromboprophylaxis (EDPTP) and Graduated compression stockings (GCS). |
| EDPTP alone | Other | Other: No Graduated compression stockingsIntervention - Extended duration pharmacological thromboprophylaxis (EDPTP) alone, no stockings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (≥18 years of age)
- Participants undergoing elective surgery; risk assessed as requiring EDPTP
Key exclusion criteria (3 listed)
- Contraindications to EDPTP or GCS
- Individuals requiring therapeutic anticoagulation e.g., anticoagulation for previous DVT
- Known thrombophilia or thrombogenic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated compression stockingsAlso: TED StockingsGraduated compression stockings are standard care (control) | Other | EDPTP plus GCS |
| No Graduated compression stockingsAlso: No TED StockingsNo Graduated compression stockings is the intervention | Other | EDPTP alone |
Primary outcome
Imaging-confirmed lower limb Deep Venous Thrombosis with or without symptoms, or Pulmonary Embolism with symptoms.
Time frame: up to 90 days post-surgery
The number of participants that have a Venous thromboembolism (VTE) event.
3 secondary outcomes
Mortality
Time frame: up to 90 days post-surgery
Adverse event
Time frame: up to 90 days post-surgery
Safety outcomes
Time frame: up to 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francine Heatley, PhD contact
Alun H Davies principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated compression stockings and No Graduated compression stockings in people with Venous Thromboembolism and Surgery, run by Imperial College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alun H Davies (0203 3117371, a.h.davies@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging-confirmed lower limb Deep Venous Thrombosis with or without symptoms, or Pulmonary Embolism with symptoms. (time frame: up to 90 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.