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

Ulcerative Colitis Clinical Trial

— SAVES-IBD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05104229
• Other study ID #: 0
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Thromboembolism
• Ulcerative Colitis
• Venous Thromboembolism

Intervention

Drug:
• Aspirin 81Mg Ec Tab
Aspirin 81Mg Ec Tab by mouth twice daily starting the day after surgery until hospital discharge, then for 30 days
• Standard of Care
Standard of Care VTE prophylaxis

Locations

Country	Name	City	State
United States	Cleveland Clinic Main Campus	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Stefan Holubar MD MS FACS, FASCRS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE Rate		30-days after discharge from hospital following IBD surgery
Secondary	Composite of bleeding requiring transfusion or intervention		30-days after discharge from hospital following IBD Surgery