Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

Launched by MCMASTER UNIVERSITY · May 1, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication to help prevent blood clots in patients with inflammatory bowel disease (IBD) who have undergone abdominal surgery. People with IBD, including those with Crohn's disease or ulcerative colitis, are at a higher risk for developing blood clots, especially after surgery. This study aims to see if giving a specific medication after surgery can reduce the chances of developing serious complications like deep vein thrombosis (DVT) or pulmonary embolism (PE).

To be eligible for the trial, participants must be over 18 years old, diagnosed with Crohn's disease or ulcerative colitis, and scheduled for an elective abdominal surgery at specific hospitals. Participants will receive either the study medication or a placebo (which looks like the medication but has no active ingredients) after their surgery. Throughout the trial, researchers will monitor participants to ensure their safety and assess how well the medication works in preventing blood clots. This study is important as it could provide valuable information for future treatments aimed at reducing health risks for IBD patients post-surgery.

Gender

ALL

Eligibility criteria

• 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