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

Stefan Holubar MD MS FACS, FASCRS

Status and phase: Withdrawn; Phase 3

Conditions: Venous Thromboembolism; Ulcerative Colitis; Crohn Disease

Treatments: Drug: Standard of Care; Drug: Aspirin 81Mg Ec Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05104229

0

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

standard VTE chemoprophylaxis

Treatment:

Drug: Standard of Care

Aspirin

Experimental group

Description:

Aspirin VTE chemoprophylaxis

Treatment:

Drug: Aspirin 81Mg Ec Tab