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Inflammatory bowel disease (IBD) is a relatively common disease that effects all age groups and carries significant morbidity and mortality. The initial treatment typically involves both short and long term medication, however when this is not enough to adequately control the disease, surgery is often required. The high morbidity and mortality rates are in part due to the increased rates of venous thromboembolism (VTE) such as deep vein thrombosis (DVT) or pulmonary embolism (PE) which have been shown to develop more frequently in IBD patients compared to the general population. Undergoing abdominal surgery has also been shown to independently increase rates of DVT and PE and since the majority of patients with IBD will undergo surgery at least once in their lifetime, the relative increased risk of developing a VTE is very high. The majority of DVT and PE events in the postoperative IBD population will occur after discharge from hospital and therefore carries significant morbidity and mortality risk in a unmonitored setting. Several studies have demonstrated the benefits and safety of twice daily dosing of oral extended VTE prophylaxis agents in orthopedic and cancer postoperative patients following discharge from hospital. There have been no randomized studies which have evaluated the use of extended postoperative VTE prophylaxis in IBD patients. The purpose of this randomized placebo controlled pilot trial will be to evaluate the efficacy and safety of postoperative VTE prophylaxis in IBD patients following abdominal surgery. If this pilot trial demonstrates efficacy in reducing postoperative DVT and PE rates, safety and feasibility, clinicians will be armed with the knowledge to pursue a larger multicenter randomized trial with the intent of reducing overall morbidity and mortality in this high risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet. |
|
| Experimental | Experimental | The treatment arm will receive a full supply of twice daily 2.5 milligram (mg) dosing of apixaban beginning on the first day of hospital discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban 2.5 milligram | Drug | 2.5 milligram daily dosing of Apixaban beginning on the first day of hospital discharge for a total of 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post operative venous thromboembolism events (DVT/PE) in in patients with Inflammatory Bowel Disease | The primary efficacy outcome will be a composite of symptomatic proximal DVTs of the upper and lower extremities, splanchnic VTE, nonfatal PE (segmental or greater artery), and death from PE and death from any cause within 3 months following hospital discharge. | 3 months post operatively |
| Incidence of bleeding while undergoing treatment with oral anticoagulant or placebo. | The primary safety outcome will be bleeding reported during treatment, including major bleeding, clinically relevant non-major (CRNM) bleeding, minor bleeding, and the composite of major bleeding and CRNM bleeding. | 3 months post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of surgical complications related to post operative anticoagulation | The secondary outcome will include surgical complications related to anticoagulation (intra-abdominal bleeding, surgical site bleeding), and arterial thromboembolic events such as acute ischemic stroke, myocardial infarction, and other VTE (upper extremity and splanchnic veins). | 3 months post operatively |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cagla Eskicioglu, MD MSc | Contact | (905) 522-1155 | 35921 | eskicio@mcmaster.ca |
| Tyler McKechnie, MD | Contact | (905) 522-1155 | 35921 | tyler.mckechnie@medportal.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41821307 | Derived | McKechnie T, Kuszaj O, Perks H, Rattansi S, Meyhofer Pedroso C, Staibano P, Thabane A, Leitch J, DuMerton D, Griffin S, Koutoukidis DA, Ramji K, Patel SV, Doumouras A, Eskicioglu C, Parpia S, Thabane L, Bhandari M. Preoperative low-energy diets for patients with a body mass index >30 kg/m2 undergoing non-bariatric surgery: pilot feasibility randomized clinical trial and a systematic review and meta-analysis of efficacy data. Br J Surg. 2026 May 7;113(5):znag023. doi: 10.1093/bjs/znag023. |
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This study will not share any individual participant data with other researchers.
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo Oral Tablet | Drug | placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration |
|
| Juravinski Hospital | Recruiting | Hamilton | Ontario | L8V 1C3 | Canada |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |