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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

We 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. We will perform an open label trial of aspirin for VTE prophylaxis compared standard of care.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Aspirin

Criteria

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