Crohn DiseasePhase 3SAVES-IBDNCT05104229
SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery
A Phase 3 study testing Aspirin 81Mg Ec Tab in people with Crohn Disease and Ulcerative Colitis, run by Stefan Holubar MD MS FACS, FASCRS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Venous Thromboembolism
- What is being tested?
- Aspirin 81Mg Ec Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age < 100 yrs
- aspirin allergy
- loop ileostomy closure
- emergency surgery
- peptic ulcer disease
- cirrhosis
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Crohn Disease, Ulcerative Colitis, Venous Thromboembolism
- Being tested
- Aspirin 81Mg Ec Tab, Standard of Care
- Keywords
- surgery, prophylaxis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81Mg Ec TabDrug
Aspirin 81Mg Ec Tab by mouth twice daily starting the day after surgery until hospital discharge, then for 30 days
Standard of CareDrug
Standard of Care VTE prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | standard VTE chemoprophylaxis Receives: Drug: Standard of Care |
| Aspirin | Experimental | Aspirin VTE chemoprophylaxis Receives: Drug: Aspirin 81Mg Ec Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE Rate
Measured: 30-days after discharge from hospital following IBD surgery
Secondary outcomes (1)
Composite of bleeding requiring transfusion or intervention
Measured: 30-days after discharge from hospital following IBD Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Jun 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Why it stopped: Limited Resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-armed open-labeled clinical trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefan Holubar MD MS FACS, FASCRS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Holubar MD MS FACS, FASCRS, The Cleveland Clinic
- Investigators
- Stefan D Holubar, MD, MS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104229
- Sponsor's protocol ID
- 0
- Acronym
- SAVES-IBD
- Status last verified
- Apr 2024
- First submitted
- 21 Oct 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05104229
- Acronym / sponsor ID
- SAVES-IBD / 0
- Conditions
- Crohn Disease, Ulcerative Colitis, Venous Thromboembolism
- Keywords
- surgery, prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Limited Resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stefan Holubar MD MS FACS, FASCRSUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-armed open-labeled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Standard of Carestandard VTE chemoprophylaxis |
| Aspirin | Experimental | Drug: Aspirin 81Mg Ec TabAspirin VTE chemoprophylaxis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- age < 100 yrs
- aspirin allergy
- loop ileostomy closure
- emergency surgery
- peptic ulcer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81Mg Ec TabAspirin 81Mg Ec Tab by mouth twice daily starting the day after surgery until hospital discharge, then for 30 days | Drug | Aspirin |
| Standard of CareStandard of Care VTE prophylaxis | Drug | Standard of Care |
Primary outcome
VTE Rate
Time frame: 30-days after discharge from hospital following IBD surgery
1 secondary outcome
Composite of bleeding requiring transfusion or intervention
Time frame: 30-days after discharge from hospital following IBD Surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan D Holubar, MD, MS principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin 81Mg Ec Tab in people with Crohn Disease and Ulcerative Colitis, run by Stefan Holubar MD MS FACS, FASCRS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE Rate (time frame: 30-days after discharge from hospital following IBD surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.