Crohn Disease, Ulcerative Colitis, Venous Thromboembolism
Conditions
Keywords
surgery, prophylaxis
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.
Interventions
Aspirin 81Mg Ec Tab by mouth twice daily starting the day after surgery until hospital discharge, then for 30 days
DRUGStandard of Care
Standard of Care VTE prophylaxis
Sponsors
Stefan Holubar MD MS FACS, FASCRS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two-armed open-labeled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VTE Rate | 30-days after discharge from hospital following IBD surgery |
Secondary
| Measure | Time frame |
|---|---|
| Composite of bleeding requiring transfusion or intervention | 30-days after discharge from hospital following IBD Surgery |
Countries
United States
Outcome results
None listed