Preventing blood clots after surgery in patients with inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of extended venous thromboprophylaxis using apixaban in patients with inflammatory bowel disease (IBD) who are undergoing abdominal surgery. The study aims to reduce the incidence of venous thromboembolism (VTE), such as deep vein thrombosis and pulmonary embolism, which are more prevalent in this patient population. Participants will be randomly assigned to receive either apixaban or a placebo following their surgery. The trial is conducted at Hamilton Health Sciences and St. Joseph's Healthcare Hamilton.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \>18 years old
* Having documented pathological diagnosis of either Crohn's disease or ulcerative colitis.
* Open or laparoscopic abdominal gastrointestinal surgery
* Elective surgery
* Surgery occurring at Hamilton Health Sciences or St. Joseph's Healthcare Hamilton
* Negative urine beta-hCG for women of childbearing potential

Exclusion Criteria:

* Contraindication to use of postoperative thromboprophylaxis (ie. Previous bleeding on anticoagulation)
* Allergy to apixaban
* History of VTE
* Current clinically significant active bleeding, including GI bleeding
* Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
* Severe renal impairment (eCrCl \<30 ml/min), or undergoing dialysis
* Lesions or conditions at increased risk of clinically significant bleeding (e.g. recent GI bleeding, recent ischemic or hemorrhagic cerebral infarction, active ulcerative GI disease, recent brain, spinal or ophthalmological surgery, bronchiectasis or history of pulmonary bleeding, thrombocytopenia or functional platelet defects, congenital or acquired coagulation disorder)
* Receiving any of the following drugs:

  * Strong inhibitors of both CYP 3A4 and P-gp, such as azole-antimycotics (e.g. ketoconazole, itraconazole, voriconazole, or posaconazole), and HIV protease inhibitors (e.g. ritonavir)
  * Strong inducers of both CYP 3A4 and P-gp (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's Wort)
  * Drug products affecting hemostasis (e.g. NSAIDs, ASA or other antiplatelet agents \[e.g. ASA, clopidogrel, prasugrel, ticagrelor\], SSRIs, or SNRIs)
  * Any other anticoagulant, including unfractionated heparin, LMWH, heparin derivatives, or oral anticoagulants (e.g. warfarin, dabigatran, rivaroxaban)
* Currently receiving therapy for any type of malignancy (e.g. colorectal, breast, lung)
* History of colorectal cancer
* Emergency surgery
* Patients with an indication for anticoagulation before surgery (atrial fibrillation, etc.)
* Enrolled in any other clinical trials or prospective studies where similar outcomes are measured
* Pregnant (i.e. positive pregnancy test and/or self-reported) and/or breastfeeding
* Women of childbearing potential unwilling/unable to participate in appropriate family planning during the treatment period

Where it's running

• St. Joseph's Healthcare
  Hamilton, Ontario, Canada Recruiting
• Juravinski Hospital
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Cagla Eskicioglu, MD MSc
• Email: eskicio@mcmaster.ca
• Phone: (905) 522-1155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.