Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery

Surgery Clinical Trial

Official title:

Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479579
• Other study ID #: 10768
• Status: Completed
• Phase: Phase 4
• Start date: February 22, 2021
• Est. completion date: November 6, 2021

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 6, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Medication
• Neoplasms
• Neoplasms Malignant
• Prophylaxis
• Surgery
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban 2.5 milligram
apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day

Locations

Country	Name	City	State
Canada	HHS-Juravinski Hospital	Hamilton	Ontario
Canada	Thrombosis Service, HHS-General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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 Apr 1. doi: — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Venous thromboembolism during prophylaxis	Symptomatic, objectively verified deep vein thrombosis of pulmonary embolism during 1st month	30 days
Other	Rate of Major bleeding during prophylaxis	Major bleeding during 1st month	30 days
Other	Rate of Clinically relevant non-major bleeding during prophylaxis	Clinically relevant non-major bleeding during 1st month	30 days
Other	Rate of Death during prophylaxis	Death during 1st month	30 days
Primary	Filled prescription	Percent of included patients that have filled their prescription for apixaban	1 week
Primary	At least 80% adherence	Percent of patients with filled prescription that have at least 80% adherence	30 days
Secondary	Rate of Venous thromboembolism post prophylaxis	The event rate of venous thromboembolism during the 2 months after planned prophylaxis	2 months

External Links

•   Publication of the study