Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery

Sponsor
McMaster University (Other)
Overall Status
Completed
CT.gov ID
NCT04479579
Collaborator
(none)
53
2
1
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26.5
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Study Details

Study Description

Brief Summary

This is a prospective, twin-center, cohort study in patients discharged from the hospital after major abdominal or pelvic cancer surgery for cancer. This study is designed to evaluate the adherence to extended deep vein thrombosis prophylaxis (DVT) with the direct oral anticoagulant apixaban on the background of historical data from the investigator's center on low-molecular-weight heparin (LMWH) substandard adherence in the same setting.

Condition or Disease Intervention/Treatment Phase
  • Drug: Apixaban 2.5 milligram
Phase 4

Detailed Description

All guidelines have embraced the concept of extended DVT prophylaxis after major abdominal or pelvic surgery for cancer, but the recommendation is consistently to use LMWH, which is more complicated than orally available prophylaxis, more expensive and has poor adherence.

The patients will be identified in the pre-operative admission or in post-operative orders as potentially eligible for extended prophylaxis. On the day of discharge a research assistant or a research nurse will approach the patient, provide information about the study and obtain written consent if the patient fulfills the eligibility criteria.

Each patient will be asked to take apixaban until postop day 29±1 and will be followed until postop day 90±3. The total duration of the study from first patient in to last patient out is expected to take 12 months.

At 1 week after discharge there is a telephone contact to ask about any side effects from apixaban or bleeding events or signs of thromboembolism and to answer any questions from the patient.

At postoperative Day +28-30 there is a telephone contact to ask about side effects, bleeding, signs of venous thromboembolism (VTE), until what date the patient has taken apixaban and estimate of missed doses using a standardized script. If the patient is still taking it, instruction will be given to discontinue. Self-reported modified Morisky Medication Adherence scale with 6 statements will be used At 90 days ±3 days there is the last telephone contact to ask about bleeding events or signs of VTE. The study is complete for the patient. At the time of Visit 4 the pharmacy that the patient uses will be contacted to provide dispensing record for apixaban, in order to verify that the patient filled the prescription.

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective cohort studyProspective cohort study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery
Actual Study Start Date :
Feb 22, 2021
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Nov 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apixaban

apixaban for extended prophylaxis against VTE after discharge

Drug: Apixaban 2.5 milligram
apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day
Other Names:
  • medication adherence assessment
  • Outcome Measures

    Primary Outcome Measures

    1. Filled prescription [1 week]

      Percent of included patients that have filled their prescription for apixaban

    2. At least 80% adherence [30 days]

      Percent of patients with filled prescription that have at least 80% adherence

    Secondary Outcome Measures

    1. Rate of Venous thromboembolism post prophylaxis [2 months]

      The event rate of venous thromboembolism during the 2 months after planned prophylaxis

    Other Outcome Measures

    1. Rate of Venous thromboembolism during prophylaxis [30 days]

      Symptomatic, objectively verified deep vein thrombosis of pulmonary embolism during 1st month

    2. Rate of Major bleeding during prophylaxis [30 days]

      Major bleeding during 1st month

    3. Rate of Clinically relevant non-major bleeding during prophylaxis [30 days]

      Clinically relevant non-major bleeding during 1st month

    4. Rate of Death during prophylaxis [30 days]

      Death during 1st month

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients of at least 18 years of age, discharged after hepato-biliary, colorectal or gynecology-oncology abdominal/pelvic surgery (laparoscopic or open) for cancer and considered at increased risk for VTE (e.g. previous history of VTE, residual cancer, slow mobilization, obesity, comorbidities).

    • Written informed consent obtained.

    Exclusion Criteria:
    • Patient unable to take tablets, even if crushed.

    • Active bleeding.

    • Venous thromboembolism diagnosed during the hospitalization.

    • Severe hepatic impairment (Child Pugh class C).

    • Severe renal failure on dialysis or with calculated creatinine clearance <15 mL/min.

    • Platelet count <50·109/L.

    • Concomitant treatment with azole-antimycotics, e.g., ketoconazole, itraconazole, voriconazole, or posaconazole, and HIV protease inhibitors, e.g., ritonavir.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thrombosis Service, HHS-General Hospital Hamilton Ontario Canada L8L 2X2
    2 HHS-Juravinski Hospital Hamilton Ontario Canada L8V 1C3

    Sponsors and Collaborators

    • McMaster University

    Investigators

    • Principal Investigator: Sam Schulman, MD, PhD, Dr.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Sam Schulman, Professor, McMaster University
    ClinicalTrials.gov Identifier:
    NCT04479579
    Other Study ID Numbers:
    • 10768
    First Posted:
    Jul 21, 2020
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Sam Schulman, Professor, McMaster University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2022