NCT03935451

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• IBD
• Venous Thromboembolism
• Crohn Disease
• Ulcerative Colitis
• Pulmonary Embolism
• Colorectal Disorders

Interventions

Type	Name	Description
DRUG	Apixaban 2.5 milligram	2.5 milligram daily dosing of Apixaban beginning on the first day of hospital discharge for a total of 30 days
DRUG	Placebo Oral Tablet	placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-12-31
• Completion: 2026-02-01
• First posted: 2019-05-02
• Last updated: 2024-01-05

Locations

2 sites across 1 country: Canada