NCT05104229WithdrawnPhase 3
SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery
SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After Major Surgery for Inflammatory Bowel Disease - A Pragmatic Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Apr 2024
Reason given: Limited Resources
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 21 Oct 2021
- Start date
- 1 Jun 2024
- Primary completion date
- 31 May 2025
- Lead sponsor
- Stefan Holubar MD MS FACS, FASCRS
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05104229
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- emergency surgery
Other illness
- aspirin allergy
- peptic ulcer disease
- bleeding or clotting disorder
- chronic renal insufficiency or failure
Lab values
- need for therapeutic anticoagulation or anti-platelet agents post-operatively including aspirin, warfarin, heparin, clopidogrel, rivaroxaban, others
Age
- age < 100 yrs
Other
- loop ileostomy closure
- cirrhosis
- thrombocytopenia
- severe anemia < 7 preoperatively
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic - Main Campus | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.