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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Crohn Disease; Ulcerative Colitis; Venous Thromboembolism
• Intervention / Treatment: Drug: Standard of Care; Drug: Aspirin 81Mg Ec Tab

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VTE Rate	30-days after discharge from hospital following IBD surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Composite of bleeding requiring transfusion or intervention	30-days after discharge from hospital following IBD Surgery

Collaborators and Investigators

• Sponsor: Stefan Holubar MD MS FACS, FASCRS
• Investigators: Principal Investigator: Stefan D Holubar, MD, MS, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: surgery; prophylaxis
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Gastroenteritis; Embolism and Thrombosis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Thromboembolism; Venous Thromboembolism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: Institute of Psychiatry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No