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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | apixaban for extended prophylaxis against VTE after discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban 2.5 milligram | Drug | apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Venous thromboembolism post prophylaxis | The event rate of venous thromboembolism during the 2 months after planned prophylaxis | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Venous thromboembolism during prophylaxis | Symptomatic, objectively verified deep vein thrombosis of pulmonary embolism during 1st month | 30 days |
| Rate of Major bleeding during prophylaxis | Major bleeding during 1st month |
Inclusion Criteria:
Exclusion Criteria:
male, female, other
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| Name | Affiliation | Role |
|---|---|---|
| Sam Schulman, MD, PhD | Dr. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thrombosis Service, HHS-General Hospital | Hamilton | Ontario | L8L 2X2 | Canada | ||
| HHS-Juravinski Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31210407 | Background | 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. | |
| 30051364 | Background |
| Label | URL |
|---|---|
| Publication of the study | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D054556 | Venous Thromboembolism |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Prospective cohort study
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| 30 days |
| Rate of Clinically relevant non-major bleeding during prophylaxis | Clinically relevant non-major bleeding during 1st month | 30 days |
| Rate of Death during prophylaxis | Death during 1st month | 30 days |
| Hamilton |
| Ontario |
| L8V 1C3 |
| Canada |
| 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. |
| 35362102 | Result | 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. |
| D010349 |
| Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |