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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

Clinicaltrials.gov identifier NCT03935451

Recruitment Status Not yet recruiting

First Posted May 2, 2019

Last update posted April 24, 2020

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.

  • Condition or Disease:Venous Thromboembolism
    Crohn Disease
    Ulcerative Colitis
    Pulmonary Embolism
    Colorectal Disorders
    IBD
  • Intervention/Treatment: Drug: Apixaban 2.5 milligram
    Drug: Placebo Oral Tablet
  • Phase: Early Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Prevention
  • Official Title: A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study
  • Estimated Study Start Date: July 2020
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2022
Arms and interventions
Arm Intervention/treatment
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.
Drug: Apixaban 2.5 milligram
2.5 milligram daily dosing of Apixaban beginning on the first day of hospital discharge for a total of 30 days
Placebo Comparator: Placebo
The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet.
Drug: Placebo Oral Tablet
placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • Secondary Outcome Measures: 1. Incidence of surgical complications related to post operative anticoagulation [ Time Frame: 3 months post operatively ]
    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).
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Exclusion Criteria:

- Contraindication to use of postoperative thromboprophylaxis (ie. Previous bleeding on
anticoagulation)

- Allergy or other contraindication to the use of apixaban

- History of VTE

- Currently receiving therapy for any type of malignancy (e.g. colorectal, breast, lung)

- History of colorectal cancer

- Emergency surgery

- Patients previously on or currently taking an oral anticoagulant

- Patients with an indication for anticoagulation before surgery (i.e. atrial
fibrillation, etc)

- Enrolled in any other clinical trials or prospective studies where similar outcomes
are measured

- Pregnant and/or breastfeeding

Contacts and Locations
Contacts

Contact: Cagla Eskicioglu, MD MSc (905) 522-1155 ext 35921 eskicio@mcmaster.ca

Contact: Jeremy Springer, MD MSc (905) 522-1155 ext 35921 jeremy.springer@medportal.ca

Locations
Sponsors and Collaborators

McMaster University

More Information
  • Responsible Party: McMaster University
  • ClinicalTrials.gov Identifier: NCT03935451 History of Changes
  • Other Study ID Numbers: 7043
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: April 24, 2020
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: This study will not share any individual participant data with other researchers.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Crohn Disease
    Colitis, Ulcerative
    Inflammatory Bowel Diseases
    Pulmonary Embolism
    Thromboembolism
    Embolism
    Venous Thromboembolism