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

NCT05104229 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Ulcerative Colitis; Venous Thromboembolism

Keywords

surgery; prophylaxis

Outcome Measures

Primary Outcomes (1)

• VTE Rate

  30-days after discharge from hospital following IBD surgery

Secondary Outcomes (1)

• Composite of bleeding requiring transfusion or intervention

  30-days after discharge from hospital following IBD Surgery

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

standard VTE chemoprophylaxis

Drug: Standard of Care

Aspirin

EXPERIMENTAL

Aspirin VTE chemoprophylaxis

Drug: Aspirin 81Mg Ec Tab

Interventions

Aspirin 81Mg Ec Tab DRUG

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

Aspirin

Standard of Care DRUG

Standard of Care VTE prophylaxis

Standard of Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefan Holubar MD MS FACS, FASCRS: lead

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Venous Thromboembolism

Interventions

Aspirin; Standard of Care

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stefan D Holubar, MD, MS

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-armed open-labeled clinical trial

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: January 1, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)