Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease (EXPAND)
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|ClinicalTrials.gov Identifier: NCT03935451|
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|IBD Venous Thromboembolism Crohn Disease Ulcerative Colitis Pulmonary Embolism Colorectal Disorders||Drug: Apixaban 2.5 milligram Drug: Placebo Oral Tablet||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study|
|Estimated Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||August 30, 2022|
Placebo Comparator: Placebo
The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet.
Drug: Placebo Oral Tablet
placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration
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.
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
- Incidence of post operative venous thromboembolism events (DVT/PE) in in patients with Inflammatory Bowel Disease [ Time Frame: 3 months post operatively ]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.
- Incidence of bleeding while undergoing treatment with oral anticoagulant or placebo. [ Time Frame: 3 months post operatively ]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.
- Incidence of surgical complications related to post operative anticoagulation [ Time Frame: 3 months post operatively ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935451
|Contact: Cagla Eskicioglu, MD MSc||(905) 522-1155 ext firstname.lastname@example.org|
|Contact: Tyler McKechnie, MD||(905) 522-1155 ext email@example.com|