The
Blood
thinner
dilemma
Do Blood Thinners Help
or Harm after surgery?
SBR Project ID
#HM02
Date of project
June 2024 – December 2029
Location
Worldwide
Type of project
Phase 4 Clinical trial
CategoRies
Tags
This project is sponsored by:
Blood clots are the body’s natural response to injury and form when blood cells clump together. However, they can be dangerous if they form in veins during or after surgery, especially after lengthy operations or if the patient has to remain in bed for a long time to recover.
Blood thinners (anticoagulants) such as ApixabanApixaban (also sold as Eliquis) is a direct oral anticoagulant (DOAC). It helps to prevent blood clotting by blocking a specific clotting factor. are often prescribed to patients who are at high risk of blood clots, as they can prevent dangerous clots, but on the flip side, they can also cause serious bleeding.
At the moment, there’s limited evidence for how medical professionals should balance these risks, especially for those who have a lower risk of developing dangerous blood clots. For this group, it’s unclear whether blood thinners offer real protection or whether they might cause more problems than they prevent.
A new study, the ARTS (Avoiding Risks of Thrombosis and Bleeding in Surgery) Trial, is designed to resolve this uncertainty, providing surgical teams and patients with the evidence needed for informed post-operative decisions.
5,436
People (over 18s)
will be recruited for the study
90
Days
of monitoring after surgery
13
Institutions involved
across 3 countries
AIMS
What we want to know
Is there a clear benefit of using the anticoagulant, Apixaban, in patients who are undergoing pelvic and abdominal surgery and who are at lower risk of clotting?
Or do the risks of major bleeding cancel any benefits out?
Importance
Why it matters
When dangerous blood clots form in the veins, it is called Deep Vein Thrombosis (DVT). DVT usually starts in the lower legs or thighs, but the blood clots can break loose and travel through your bloodstream. This can be fatal if they block a lung artery, creating a Pulmonary embolism (PE). Together, DVT and PE are known as venous thromboembolism (VTE).
Medical professionals need to know how best to help their patient during post-surgical care. We hope to gather the evidence to help them make informed decisions.
Any of the possible outcomes of the study will improve care for thousands of patients every year:
Clear net Benefit
If Apixaban shows clear benefit in lower risk patients → Doctors can confidently use it to help prevent blood clots.
More Harm Than Good
If Apixaban causes more bleeding problems than it prevents clotting issues in lower risk patients → Doctors can avoid it.
Balanced Trade-offs
If benefits and disadvantages are balanced → Doctors can make the choice based on the individual patient.
Project
So we set up a study
ARTS will be the first large trial to compare using Apixaban (a blood thinner) versus no blood thinners in patients undergoing abdominal or pelvic surgery.
We aim to recruit 5,436 people (over 18s), who are undergoing pelvic or abdominal surgery and who are at similar (and not high) risk of blood clots and bleeding. They will be randomly assigned to two groups, both receiving standard care:
Group A:
Given Apixaban
(2.5mg taken orally, twice daily for 28 days)
Group B:
No Apixaban
What we will measure:
Incidence of VTE after 30 and 90 days
What’s this?
Did the patient get VTE (deep vein thrombosis or pulmonary embolism (blood clots in the lung) in the 30 and 90 days after surgery?
Incidence of major bleeding (hematoma, hemorrhage) at 30 days and 90 days?
Cost-effectiveness
What’s this?
This includes hospital costs, patients’ time off work, incapacity benefits, travel and parking related to health appointments, and other health-related expenses.
Overall mortality in the 30 and 90 days post surgery
Adverse or side effects from Apixaban
Other complications such as admittance to Intensive Care or other additional interventions required.
FAQ
Frequently Asked Questions
Q: Is this study safe?
A: The study is carefully monitored with strict safety protocols. Both approaches (using Apixaban or not) are currently used in clinical practice and we’re testing which is better.
Q: Why are we focusing on abdominal and pelvic surgeries?
A: Apixaban and other direct oral anticoagulants are well studied in orthopedic surgery, atrial fibrillation, and treatment of blood clots, but not after abdominal and pelvic surgery. In these surgeries, patients may face both clotting and bleeding risks, so it is still unclear whether anticoagulation does more good than harm. ARTS is designed to answer that question.
Q: Why is deciding to prescribe blood thinners difficult in some cases?
A: Blood thinners can prevent clots, but they can also cause bleeding. For some patients after surgery, the risks are balanced closely enough that doctors do not yet know which approach is best. ARTS is studying this group.
Q: Why would a patient be ‘high risk’?
A: Certain factors can increase someone’s risk of blood clots, including older age, obesity, pregnancy, and a history of DVT.
Q: Why are patients monitored for 90 days?
Patients are most at risk of VTE 2-10 days after surgery, but it can occur up to three months afterwards.
Timeline
The long journey
Data collection is expected to take four years. Results will be published within 12 months after completion.
Study begins
Approval granted
Study Ends
Analysis begins
team
Who are we?
Lead Investigator
Clinical Urology and Epidemiology Working Group
University of Helsinki and Helsinki University Central Hospital
MD Sara Tornberg
Helsinki University Hospital Helsinki, Finland
Canada
McMaster University
Hamilton, Ontario, Canada
Population Health Research Institute
Hamilton, Ontario, Canada
Finland
Helsinki University Central Hospital
Helsinki, Finland
North Karelia Central Hospital
Joensuu, Finland
Oulu University Hospital
Oulu, Finland
Päijät-Häme Central Hospital
Lahti, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
University of Helsinki
Helsinki, Finland
United States
Albany Medical College
Albany, New York, USA
Harvard University
Boston, Massachusetts, USA
Northwestern University
Chicago, Illinois, USA
Yale University
New Haven, Connecticut, USA
Sigrid Jusélius Foundation
Syöpäsäätiö / Cancer Foundation Finland
Helsinki University Central Hospital
The Accelerating Clinical Trials (ACT) Consortium (Canada)
Hamilton Academic Health Sciences Organization (HAHSO)
McMaster University
Tays Tukisäätiö
Oulu Hospital District
Turku Hospital District
Tampere Hospital District
This study couldn’t be done without all the participants, investigators, and staff involved. Thanks to all of you for your support.
CONTACT
Get Involved
THIS STUDY IS ACTIVELY RECRUITING
Do you have questions about the ARTS trial or want to find out if you’re eligible to participate? Contact the research team:
Study Contact :
Name: CLUE Working Group
Phone Number: +358-40-5791034
Email: [email protected]
Official title of study:
Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial: An International Randomised Controlled Trial Evaluating Apixaban Versus No Anticoagulation in Patients Undergoing General Abdominal, Gynecologic and Urologic Surgery
ClinicalTrials.gov ID:
NCT06523959
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