STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism
Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
Summary
Pulmonary embolisms (PE) occur when blood clots cause a blockage of the blood supply to the
lungs. A small PE located in the subsegmental pulmonary vasculature is identified as a
subsegmental PE (SSPE). Anticoagulants are used to treat SSPE and work by preventing new
clots from forming whilst the body's own mechanisms break down the clots, however they can
also increase the risk of major and potentially life threatening bleeding. More recent
observational data of routine care for SSPE showed very high complication rates of
anticoagulation but in patients where treatment was withheld, this proved to be a safe
strategy in terms of recurrent venous thromboembolism (VTE).
Computed tomography pulmonary angiography (CTPA) scans are now able to detect SSPE, however
there are concerns that there is an over-diagnosis due to the incorrect interpretation of
small artefacts. 1466 patients from approximately 50 sites will be recruited, these sites
will consist of hospitals across the United Kingdom (UK). Patients 18 and over with isolated
SSPE, confirmed by either CTPA or CT thorax with IV contrast, will be eligible for the trial.
Patients will be randomised to either receive standard anticoagulation for at least 3 months
(control) or no anticoagulation for at least 3 months (intervention). The participant will
receive telephone follow up calls at 4, 12 and 24 weeks following the end of their treatment,
and additional data will also be taken from their medical records at these time points. The
participant isn't required to be contacted for the 52 week follow up as the data will be
extracted from the National Health Service (NHS) Digital collection of Hospital Episode
Statistics (HES). In total participation in the study will last 12 months. In addition the
cost-effectiveness of no treatment versus treatment with full anticoagulation will be looked
at and also improving on radiological diagnosis of SSPE.
Phase:
Phase 3
Details
Lead Sponsor:
University of Birmingham
Collaborators:
Cimar Royal United Hospitals Bath NHS Foundation Trust