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Anticoagulant

Aspirin for Blood Clot Prevention After IBD Surgery (SAVES-IBD Trial)

Phase 3

Waitlist Available

Led By Stefan D Holubar, MD, MS

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Major abdominopelvic surgery with colon or rectal resection

Preoperative diagnosis of Crohn's disease, ulcerative colitis, indeterminate colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-days after discharge from hospital following ibd surgery

Awards & highlights

SAVES-IBD Trial Summary

This trial will test whether aspirin is effective and safe to prevent blood clots in IBD patients who have had major abdominal surgery.

Who is the study for?

This trial is for adults over 18 who are having major surgery for Crohn's disease or ulcerative colitis and can receive standard blood clot prevention. It's not for those with aspirin allergies, emergency surgeries, stomach ulcers, liver issues, bleeding disorders, severe kidney problems or anemia.Check my eligibility

What is being tested?

The study tests if a low-dose aspirin (81 mg) taken twice daily is as safe and effective as the usual care in preventing blood clots after intestinal surgery in IBD patients. Participants will either get this new approach or follow standard practices.See study design

What are the potential side effects?

Potential side effects of taking low-dose aspirin may include increased risk of bleeding, gastrointestinal issues like stomach pain or heartburn, and possibly allergic reactions in those sensitive to aspirin.

SAVES-IBD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had major surgery in my abdomen or pelvis, including removal of part of my colon or rectum.

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I have been diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis before surgery.

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I am planning to have elective surgery.

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I am older than 18 years.

SAVES-IBD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-days after discharge from hospital following ibd surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-days after discharge from hospital following ibd surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-days after discharge from hospital following ibd surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

VTE Rate

Secondary outcome measures

Composite of bleeding requiring transfusion or intervention

SAVES-IBD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AspirinExperimental Treatment1 Intervention

Aspirin VTE chemoprophylaxis

Group II: Standard of CareActive Control1 Intervention

standard VTE chemoprophylaxis

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,364,186 Total Patients Enrolled

Stefan D Holubar, MD, MSPrincipal InvestigatorThe Cleveland Clinic

Media Library

Standard of Care (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05104229 — Phase 3

Deep Vein Thrombosis Research Study Groups: Standard of Care, Aspirin

Deep Vein Thrombosis Clinical Trial 2023: Standard of Care Highlights & Side Effects. Trial Name: NCT05104229 — Phase 3

Standard of Care (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05104229 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people of all ages participate in this research?

"The study is open to individuals that are aged 18 or above, and below 100 years old."

Answered by AI

Are there any dangers to taking Aspirin 81Mg Ec Tab?

"There is some data to support the efficacy of Aspirin 81Mg Ec Tab, and it has undergone multiple rounds of testing for safety. Consequently, our team at Power has given it a score of 3."

Answered by AI

Could I possibly help with this research by enrolling in the trial?

"This study is for patients with ileocolitis who are between 18-100 years old. Around 1890 people are needed for the trial."

Answered by AI

What conditions does Aspirin 81Mg Ec Tab typically relieve?

"Aspirin 81Mg Ec Tab is most frequently used to help patients who have undergone percutaneous coronary intervention (pci). However, it can also be taken to mitigate conditions like dental procedures, inflammation, and neck pain."

Answered by AI

How many individuals are in the experimental group for this research project?

"Unfortunately, this particular trial is not currently seeking patients. Although, it's worth noting that the date when this study was last updated was July 19th, 2022. Additionally, there are presently 506 clinical trials actively enrolling participants with ileocolitis and 181 studies for Aspirin 81Mg Ec Tab actively looking for participants."

Answered by AI

Are new participants still being accepted for this clinical trial?

"As of July 19th, 2022, this particular trial is no longer actively recruiting patients. If you are interested in other clinical trials, there are 506 studies for ileocolitis and 181 for Aspirin 81Mg Ec Tab that are still looking for participants."

Answered by AI

Have similar medical trials been conducted before?

"Since 2002, when the first clinical trial was completed, research on Aspirin 81Mg Ec Tab has progressed. The initial study, which had 413 participants and was sponsored by Sanofi, took place in 2002. After the success of this Phase 3 drug trial, Aspirin 81Mg Ec Tab received its approval for use. Now, there are 181 active trials being conducted in 1451 cities and 61 nations across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stefan Holubar MD MS FACS, FASCRS 2024. "SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05104229.

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