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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05104229

Collaborator

(none)

1,890

Enrollment

Location

Arms

19.1

Anticipated Duration (Months)

99.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease Ulcerative Colitis Venous Thromboembolism	Drug: Aspirin 81Mg Ec Tab Drug: Standard of Care	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1890 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two-armed open-labeled clinical trialTwo-armed open-labeled clinical trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care standard VTE chemoprophylaxis	Drug: Standard of Care Standard of Care VTE prophylaxis
Experimental: Aspirin Aspirin VTE chemoprophylaxis	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

Arm

Intervention/Treatment

Active Comparator: Standard of Care

standard VTE chemoprophylaxis

Drug: Standard of Care

Standard of Care VTE prophylaxis

Experimental: Aspirin

Aspirin VTE chemoprophylaxis

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

Outcome Measures

Primary Outcome Measures

VTE Rate [30-days after discharge from hospital following IBD surgery]

Secondary Outcome Measures

Composite of bleeding requiring transfusion or intervention [30-days after discharge from hospital following IBD Surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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