Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease
Status:
Recruiting
Trial end date:
2022-08-30
Target enrollment:
Participant gender:
Summary
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.