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Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease (EXPAND)

Primary Purpose

IBD, Venous Thromboembolism, Crohn Disease

Status

Recruiting

Phase

Early Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Apixaban 2.5 milligram

Placebo Oral Tablet

About this trial

This is an interventional prevention trial for IBD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

>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

Exclusion Criteria:

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
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

Sites / Locations

St. Joseph's HealthcareRecruiting
Juravinski HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Experimental

Arm Description

The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT03935451

First Posted

April 23, 2019

Last Updated

August 26, 2022

Sponsor

McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT03935451

Brief Title

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

Acronym

EXPAND

Official Title

A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

February 28, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IBD, Venous Thromboembolism, Crohn Disease, Ulcerative Colitis, Pulmonary Embolism, Colorectal Disorders

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet.

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Apixaban 2.5 milligram

Intervention Description

2.5 milligram daily dosing of Apixaban beginning on the first day of hospital discharge for a total of 30 days

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration

Primary Outcome Measure Information:

Title

Incidence of post operative venous thromboembolism events (DVT/PE) in in patients with Inflammatory Bowel Disease

Description

Time Frame

3 months post operatively

Title

Incidence of bleeding while undergoing treatment with oral anticoagulant or placebo.

Description

Time Frame

3 months post operatively

Secondary Outcome Measure Information:

Title

Incidence of surgical complications related to post operative anticoagulation

Description

Time Frame

3 months post operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: >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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cagla Eskicioglu, MD MSc

Phone

(905) 522-1155

Ext

35921

eskicio@mcmaster.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Tyler McKechnie, MD

Phone

(905) 522-1155

Ext

35921

tyler.mckechnie@medportal.ca

Facility Information:

Facility Name

St. Joseph's Healthcare

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cagla Eskicioglu, MD

Phone

(905) 522-1155

Ext

35921

eskicio@mcmaster.ca

Facility Name

Juravinski Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 1C3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shawn Forbes, MD

sforbes@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This study will not share any individual participant data with other researchers.

Learn more about this trial

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

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