IBDEarly Phase 1EXPANDNCT03935451
Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease
A Early Phase 1 study testing Apixaban 2.5 milligram in people with IBD and Venous Thromboembolism, run by McMaster University at 2 sites in Canada.
Trial summary
Inflammatory bowel disease (IBD) is a relatively common disease that effects all age groups and carries significant morbidity and mortality. The initial treatment typically involves both short and long term medication, however when this is not enough to adequately control the disease, surgery is often required. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD, Venous Thromboembolism, Crohn Disease
- What is being tested?
- Apixaban 2.5 milligram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2021to 1 Feb 2026
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old
- Having documented pathological diagnosis of either Crohn's disease or ulcerative colitis.
- Open or laparoscopic abdominal gastrointestinal surgery
- Elective surgery
- Surgery occurring at Hamilton Health Sciences or St. Joseph's Healthcare Hamilton
- Negative urine beta-hCG for women of childbearing potential
Who cannot join
- Contraindication to use of postoperative thromboprophylaxis (ie. Previous bleeding on anticoagulation)
- Allergy to apixaban
- History of VTE
- Current clinically significant active bleeding, including GI bleeding
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Severe renal impairment (eCrCl <30 ml/min), or undergoing dialysis
Show all 19Show fewer
- Lesions or conditions at increased risk of clinically significant bleeding (e.g. recent GI bleeding, recent ischemic or hemorrhagic cerebral infarction, active ulcerative GI disease, recent brain, spinal or ophthalmological surgery, bronchiectasis or history of pulmonary bleeding, thrombocytopenia or functional platelet defects, congenital or acquired coagulation disorder)
- Receiving any of the following drugs:
- Strong inhibitors of both CYP 3A4 and P-gp, such as azole-antimycotics (e.g. ketoconazole, itraconazole, voriconazole, or posaconazole), and HIV protease inhibitors (e.g. ritonavir)
- Strong inducers of both CYP 3A4 and P-gp (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's Wort)
- Drug products affecting hemostasis (e.g. NSAIDs, ASA or other antiplatelet agents [e.g. ASA, clopidogrel, prasugrel, ticagrelor], SSRIs, or SNRIs)
- Any other anticoagulant, including unfractionated heparin, LMWH, heparin derivatives, or oral anticoagulants (e.g. warfarin, dabigatran, rivaroxaban)
- Currently receiving therapy for any type of malignancy (e.g. colorectal, breast, lung)
- History of colorectal cancer
- Emergency surgery
- Patients with an indication for anticoagulation before surgery (atrial fibrillation, etc.)
- Enrolled in any other clinical trials or prospective studies where similar outcomes are measured
- Pregnant (i.e. positive pregnancy test and/or self-reported) and/or breastfeeding
- Women of childbearing potential unwilling/unable to participate in appropriate family planning during the treatment period
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Cagla Eskicioglu, MD, (905) 522-1155 ext. 35921, eskicio@mcmaster.ca
- Recruiting
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Shawn Forbes, MD, sforbes@mcmaster.ca
About this study
Official title: A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study
Inflammatory bowel disease (IBD) is a relatively common disease that effects all age groups and carries significant morbidity and mortality. The initial treatment typically involves both short and long term medication, however when this is not enough to adequately control the disease, surgery is often required. The high morbidity and mortality rates are in part due to the increased rates of venous thromboembolism (VTE) such as deep vein thrombosis (DVT) or pulmonary embolism (PE) which have been shown to develop more frequently in IBD patients compared to the general population. Undergoing abdominal surgery has also been shown to independently increase rates of DVT and PE and since the majority of patients with IBD will undergo surgery at least once in their lifetime, the relative increased risk of developing a VTE is very high. The majority of DVT and PE events in the postoperative IBD population will occur after discharge from hospital and therefore carries significant morbidity and mortality risk in a unmonitored setting. Several studies have demonstrated the benefits and safety of twice daily dosing of oral extended VTE prophylaxis agents in orthopedic and cancer postoperative patients following discharge from hospital. There have been no randomized studies which have evaluated the use of extended postoperative VTE prophylaxis in IBD patients. The purpose of this randomized placebo controlled pilot trial will be to evaluate the efficacy and safety of postoperative VTE prophylaxis in IBD patients following abdominal surgery. If this pilot trial demonstrates efficacy in reducing postoperative DVT and PE rates, safety and feasibility, clinicians will be armed with the knowledge to pursue a larger multicenter randomized trial with the intent of reducing overall morbidity and mortality in this high risk population.
- Conditions
- IBD, Venous Thromboembolism, Crohn Disease, Ulcerative Colitis, Pulmonary Embolism, Colorectal Disorders
- Being tested
- Apixaban 2.5 milligram, Placebo Oral Tablet
- Medical subject headings
- Venous Thromboembolism, Crohn Disease, Colitis, Ulcerative, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 milligramDrug
2.5 milligram daily dosing of Apixaban beginning on the first day of hospital discharge for a total of 30 days
Placebo Oral TabletDrug
placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet. Receives: Drug: Placebo Oral Tablet |
| Experimental | Experimental | The treatment arm will receive a full supply of twice daily 2.5 milligram (mg) dosing of apixaban beginning on the first day of hospital discharge. Receives: Drug: Apixaban 2.5 milligram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post operative venous thromboembolism events (DVT/PE) in in patients with Inflammatory Bowel Disease
The primary efficacy outcome will be a composite of symptomatic proximal DVTs of the upper and lower extremities, splanchnic VTE, nonfatal PE (segmental or greater artery), and death from PE and death from any cause within 3 months following hospital discharge.
Measured: 3 months post operatively
Incidence of bleeding while undergoing treatment with oral anticoagulant or placebo.
The primary safety outcome will be bleeding reported during treatment, including major bleeding, clinically relevant non-major (CRNM) bleeding, minor bleeding, and the composite of major bleeding and CRNM bleeding.
Measured: 3 months post operatively
Secondary outcomes (1)
Incidence of surgical complications related to post operative anticoagulation
The secondary outcome will include surgical complications related to anticoagulation (intra-abdominal bleeding, surgical site bleeding), and arterial thromboembolic events such as acute ischemic stroke, myocardial infarction, and other VTE (upper extremity and splanchnic veins).
Measured: 3 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935451
- Sponsor's protocol ID
- 7043
- Acronym
- EXPAND
- Status last verified
- Jan 2024
- First submitted
- 23 Apr 2019
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share any individual participant data with other researchers.
Publications
McKechnie T, Kuszaj O, Perks H, Rattansi S, Meyhofer Pedroso C, Staibano P, Thabane A, Leitch J, DuMerton D, Griffin S, Koutoukidis DA, Ramji K, Patel SV, Doumouras A, Eskicioglu C, Parpia S, Thabane L, Bhandari M. Preoperative low-energy diets for patients with a body mass index >30 kg/m2 undergoing non-bariatric surgery: pilot feasibility randomized clinical trial and a systematic review and meta-analysis of efficacy data. Br J Surg. 2026 May 7;113(5):znag023. doi: 10.1093/bjs/znag023.
PubMed 41821307
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT03935451
- Acronym / sponsor ID
- EXPAND / 7043
- Conditions
- IBD, Venous Thromboembolism, Crohn Disease, Ulcerative Colitis, Pulmonary Embolism, Colorectal Disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 2 May 2019 (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.
Inflammatory bowel disease (IBD) is a relatively common disease that effects all age groups and carries significant morbidity and mortality. The initial treatment typically involves both short and long term medication, however when this is not enough to adequately control the disease, surgery is often required. The high morbidity and mortality rates are in part due to the increased rates of venous thromboembolism (VTE) such as deep vein thrombosis (DVT) or pulmonary embolism (PE) which have been shown to develop more frequently in IBD patients compared to the general population. Undergoing abdominal surgery has also been shown to independently increase rates of DVT and PE and since the majority of patients with IBD will undergo surgery at least once in their lifetime, the relative increased risk of developing a VTE is very high. The majority of DVT and PE events in the postoperative IBD population will occur after discharge from hospital and therefore carries significant morbidity and mortality risk in a unmonitored setting. Several studies have demonstrated the benefits and safety of twice daily dosing of oral extended VTE prophylaxis agents in orthopedic and cancer postoperative patients following discharge from hospital. There have been no randomized studies which have evaluated the use of extended postoperative VTE prophylaxis in IBD patients. The purpose of this randomized placebo controlled pilot trial will be to evaluate the efficacy and safety of postoperative VTE prophylaxis in IBD patients following abdominal surgery. If this pilot trial demonstrates efficacy in reducing postoperative DVT and PE rates, safety and feasibility, clinicians will be armed with the knowledge to pursue a larger multicenter randomized trial with the intent of reducing overall morbidity and mortality in this high risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Oral TabletThe placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet. |
| Experimental | Experimental | Drug: Apixaban 2.5 milligramThe treatment arm will receive a full supply of twice daily 2.5 milligram (mg) dosing of apixaban beginning on the first day of hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years old
- Having documented pathological diagnosis of either Crohn's disease or ulcerative colitis.
- Open or laparoscopic abdominal gastrointestinal surgery
- Elective surgery
- Surgery occurring at Hamilton Health Sciences or St. Joseph's Healthcare Hamilton
Key exclusion criteria (19 listed)
- Contraindication to use of postoperative thromboprophylaxis (ie. Previous bleeding on anticoagulation)
- Allergy to apixaban
- History of VTE
- Current clinically significant active bleeding, including GI bleeding
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
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 |
|---|---|---|
| Apixaban 2.5 milligram2.5 milligram daily dosing of Apixaban beginning on the first day of hospital discharge for a total of 30 days | Drug | Experimental |
| Placebo Oral Tabletplacebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration | Drug | Placebo |
Primary outcome
Incidence of post operative venous thromboembolism events (DVT/PE) in in patients with Inflammatory Bowel Disease
Time frame: 3 months post operatively
The primary efficacy outcome will be a composite of symptomatic proximal DVTs of the upper and lower extremities, splanchnic VTE, nonfatal PE (segmental or greater artery), and death from PE and death from any cause within 3 months following hospital discharge.
Incidence of bleeding while undergoing treatment with oral anticoagulant or placebo.
Time frame: 3 months post operatively
The primary safety outcome will be bleeding reported during treatment, including major bleeding, clinically relevant non-major (CRNM) bleeding, minor bleeding, and the composite of major bleeding and CRNM bleeding.
1 secondary outcome
Incidence of surgical complications related to post operative anticoagulation
Time frame: 3 months post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 41821307McKechnie T, Kuszaj O, Perks H, Rattansi S, Meyhofer Pedroso C, Staibano P, Thabane A, Leitch J, DuMerton D, Griffin S, Koutoukidis DA, Ramji K, Patel SV, Doumouras A, Eskicioglu C, Parpia S, Thabane L, Bhandari M. Preoperative low-energy diets for patients with a body mass index >30 kg/m2 undergoing non-bariatric surgery: pilot feasibility randomized clinical trial and a systematic review and meta-analysis of efficacy data. Br J Surg. 2026 May 7;113(5):znag023. doi: 10.1093/bjs/znag023.
- Individual participant dataSharing planned: No. This study will not share any individual participant data with other researchers.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Apixaban 2.5 milligram in people with IBD and Venous Thromboembolism, run by McMaster University at 2 sites in Canada.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cagla Eskicioglu, MD MSc ((905) 522-1155 ext. 35921, eskicio@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post operative venous thromboembolism events (DVT/PE) in in patients with Inflammatory Bowel Disease (time frame: 3 months post operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935451, which also lists 1 linked publication.
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 5 Jan 2024.