Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06166537 |
| Other study ID # |
22HH7932 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 27, 2024 |
| Est. completion date |
March 31, 2027 |
Study information
| Verified date |
May 2024 |
| Source |
Imperial College London |
| Contact |
Alun H Davies |
| Phone |
0203 3117371 |
| Email |
a.h.davies[@]imperial.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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:
A) 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.
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:-
1. patients undergoing surgical procedures requiring EDPTP benefit from additional GCS to
prevent VTE
2. 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:
1. EDPTP* in addition to GCS, or
2. 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.
