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

NCT ID: NCT05104229

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-01-01

Brief 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.

Detailed 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.

Conditions

Crohn Disease; Ulcerative Colitis; Venous Thromboembolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

standard VTE chemoprophylaxis

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

Standard of Care VTE prophylaxis

Aspirin

Aspirin VTE chemoprophylaxis

Group Type: EXPERIMENTAL

Aspirin 81Mg Ec Tab

Intervention Type: DRUG

Aspirin 81Mg Ec Tab by mouth twice daily starting the day after surgery until hospital discharge, then for 30 days

Interventions

Aspirin 81Mg Ec Tab

Aspirin 81Mg Ec Tab by mouth twice daily starting the day after surgery until hospital discharge, then for 30 days

Intervention Type: DRUG

Standard of Care

Standard of Care VTE prophylaxis

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stefan Holubar MD MS FACS, FASCRS

OTHER

Sponsor Role: lead

Responsible Party

Stefan Holubar MD MS FACS, FASCRS

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stefan D Holubar, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

0

Identifier Type: -

Identifier Source: org_study_id