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Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease (EXPAND)

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ClinicalTrials.gov Identifier: NCT03935451
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date February 24, 2021
Estimated Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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, 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease
Official Title  ICMJE A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • IBD
  • Venous Thromboembolism
  • Crohn Disease
  • Ulcerative Colitis
  • Pulmonary Embolism
  • Colorectal Disorders
Intervention  ICMJE
  • 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
  • Drug: Placebo Oral Tablet
    placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet.
    Intervention: 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.
    Intervention: Drug: Apixaban 2.5 milligram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2019)
180
Estimated Study Completion Date  ICMJE August 30, 2022
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cagla Eskicioglu, MD MSc (905) 522-1155 ext 35921 eskicio@mcmaster.ca
Contact: Tyler McKechnie, MD (905) 522-1155 ext 35921 tyler.mckechnie@medportal.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935451
Other Study ID Numbers  ICMJE 7043
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This study will not share any individual participant data with other researchers.
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McMaster University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP