NCT04479579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2021

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

July 16, 2020

Last Update Submit

April 14, 2022

Conditions

Neoplasms MalignantSurgeryVenous ThromboembolismProphylaxisAdherence, Medication

Keywords

apixabanabdominalpelvic

Outcome Measures

Primary Outcomes (2)

  • Filled prescription

    Percent of included patients that have filled their prescription for apixaban

    1 week

  • At least 80% adherence

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

    30 days

Secondary Outcomes (1)

  • Rate of Venous thromboembolism post prophylaxis

    2 months

Other Outcomes (4)

  • Rate of Venous thromboembolism during prophylaxis

    30 days

  • Rate of Major bleeding during prophylaxis

    30 days

  • Rate of Clinically relevant non-major bleeding during prophylaxis

    30 days

  • +1 more other outcomes

Study Arms (1)

Apixaban

EXPERIMENTAL

apixaban for extended prophylaxis against VTE after discharge

Drug: Apixaban 2.5 milligram

Interventions

Apixaban 2.5 milligramDRUG

apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day

Also known as: medication adherence assessment
Apixaban

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale, female, other
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thrombosis Service, HHS-General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

HHS-Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (3)

  • Serrano PE, Parpia S, Valencia M, Simunovic M, Bhandari M, Levine M. Incidence of delayed venous thromboembolic events in patients undergoing abdominal and pelvic surgery for cancer: a systematic review and meta-analysis. ANZ J Surg. 2019 Oct;89(10):1217-1223. doi: 10.1111/ans.15290. Epub 2019 Jun 18.

    PMID: 31210407BACKGROUND

  • Serrano PE, Parpia S, Linkins LA, Elit L, Simunovic M, Ruo L, Bhandari M, Levine M. Venous Thromboembolic Events Following Major Pelvic and Abdominal Surgeries for Cancer: A Prospective Cohort Study. Ann Surg Oncol. 2018 Oct;25(11):3214-3221. doi: 10.1245/s10434-018-6671-7. Epub 2018 Jul 26.

    PMID: 30051364BACKGROUND

  • Schulman S, Carlson V, Serrano PE, Sne N, Kahnamoui K, Mithoowani S, Ikesaka R, Gross PL. Adherence to apixaban for extended thromboprophylaxis after major abdominal or pelvic surgery for cancer: A prospective cohort study. J Surg Oncol. 2022 Aug;126(2):386-393. doi: 10.1002/jso.26876. Epub 2022 Apr 1.

    PMID: 35362102RESULT

Related Links

MeSH Terms

Conditions

NeoplasmsVenous ThromboembolismMedication Adherence

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sam Schulman, MD, PhD

    Dr.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

February 22, 2021

Primary Completion

October 31, 2021

Study Completion

November 6, 2021

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)