SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery

Study Overview
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Brief Summary
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Aim to determine if aspirin 81 mg orally twice daily is effective and safe as an extended VTE chemoprophylaxis agent after major abdominal surgery for IBD patients. Study will perform an open label trial of aspirin for VTE prophylaxis compared standard of care.

Detailed Description
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Patients with inflammatory bowel disease who undergo abdominopelvic intestinal surgery are at increased risk for developing venous thromboembolism, in the form of deep vein thrombosis, pulmonary embolism and mesenteric vein thrombosis for 90-days after surgery. Despite being high-risk, the standard of care is to provide mechanical and chemoprophylaxis (unfractionated heparin or low molecular weight heparin) only while they are hospitalized. There exists randomized data, in patients who have had surgery for abdominopelvic cancer, confirming the efficacy of extended post-discharge chemoprophylaxis with either unfractionated heparin or low molecular weight heparin for 28 days after surgery, but no such data exists for IBD. There has been a resistance to adopting this for IBD patients due to compliance and cost of the daily injections. However, recently, a large, multicenter, randomized trial in >3000 patients who underwent total hip or total knee replacement found that extended aspirin (81 mg) twice daily post-discharge was both equivalent and non-inferior to prophylaxis using full-strength anticoagulation with a factor Xa inhibitor. This is a prospective, multicenter, open label clinical trial to assess the safety and efficacy of post-operative venous thromboembolism (VTE) prophylaxis with aspirin 81 mg orally twice daily for 30-days after surgery for IBD compared with controls receiving standard of care.

Official Title
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SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After Major Surgery for Inflammatory Bowel Disease - A Pragmatic Clinical Trial

Conditions
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Crohn Disease, Ulcerative Colitis, Venous Thromboembolism

Intervention / Treatment
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* Drug: Aspirin 81Mg Ec Tab
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18yrs Major abdominopelvic surgery with colon or rectal resection Preoperative diagnosis of Crohn's disease, ulcerative colitis, indeterminate colitis Elective surgery candidate for standard of care VTE prophylaxis Exclusion Criteria: age < 100 yrs aspirin allergy loop ileostomy closure emergency surgery peptic ulcer disease cirrhosis bleeding or clotting disorder thrombocytopenia chronic renal insufficiency or failure severe anemia < 7 preoperatively need for therapeutic anticoagulation or anti-platelet agents post-operatively including aspirin, warfarin, heparin, clopidogrel, rivaroxaban, others

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-armed open-labeled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>standard VTE chemoprophylaxis | Drug: Standard of Care<br>* Standard of Care VTE prophylaxis<br>|
| Experimental: Aspirin<br>Aspirin VTE chemoprophylaxis | Drug: Aspirin 81Mg Ec Tab<br>* Aspirin 81Mg Ec Tab by mouth twice daily starting the day after surgery until hospital discharge, then for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE Rate |  | 30-days after discharge from hospital following IBD surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of bleeding requiring transfusion or intervention |  | 30-days after discharge from hospital following IBD Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, prophylaxis