Clinical trial NCT05104229: SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Crohn Disease
Ulcerative Colitis
Venous Thromboembolism
Keywords: surgery
prophylaxis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed open-labeled clinical trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: VTE Rate
timeFrame: 30-days after discharge from hospital following IBD surgery
Secondary outcomes:
measure: Composite of bleeding requiring transfusion or intervention
timeFrame: 30-days after discharge from hospital following IBD Surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Stefan D Holubar, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: