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Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Patients with CRC are underrepresented in the major trials examining treatment of cancer-associated VTE with anticoagulant.
Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Specifically, a subsequent analysis of the Hokusai study showed that the excess in MB was confined to patients with gastrointestinal cancer. In the RIETE registry, patients with gastrointestinal or genitourinary cancers experienced more bleeding outcomes while patients with brain or lung cancer experienced more thrombotic outcomes. However, in a subgroup analysis of the Caravaggio trial, major gastrointestinal bleeding in patients with CRC was low and similar in both apixaban and LMWH groups. Patients with CRC are underrepresented in the major trials examining treatment of CAT with anticoagulant. Despite concerns that DOACs pose a significant bleeding risk in CRC patients, many patients with CRC are treated with apixaban or rivaroxaban in clinical practice. Balancing risks of thrombosis recurrence and bleeding can be challenging and requires a nuanced, individualized approach to decision making to improve prognosis in this population. The aim of this study is to identify risk factors for recurrence and bleeding in CRC patients with VTE. Deaths, regardless of the mechanism, will also be included in the one year all-cause mortality outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with adverse anticoagulant outcomes | Patients with adverse anticoagulant outcomes in the study period. Adverse anticoagulant outcomes include venous thromboembolism recurrence, major bleeding, and clinical relevant non major bleeding. |
| |
| Patients without any adverse anticoagulant outcomes | Patients without any adverse anticoagulant outcomes in the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | A prospectively maintained database query of all patients with CRC and VTE was initially performed, and then each patient's electronic record was reviewed for inclusion criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| recurrent VTE including deep vein thrombosis (DVT) and pulmonary embolism (PE) | Recurrent DVT had to be confirmed by duplex ultrasonography, venography, CT, or MRI. Recurrent PE was confirmed by CT, MRI, conventional pulmonary angiography, or VQ (ventilation/perfusion) imaging. Fatal PE had to be based on objective diagnostic testing, autopsy, or death that could not be attributed to a documented cause and for which PE/DVT could not be ruled out (unexplained death). Incidental VTE recurrence had to be identified via surveillance-related imaging. To be classified as a recurrent event, a new filling defect had to be evident on the second study, not appreciated on the original images, or an interval study clearly showing thrombus resolution. | From the date of index VTE to VTE recurrence, assessed up to 12 months |
| Major Bleeding (MB) | MB was defined as overt bleeding plus a hemoglobin decrease of ≥ 2 g/dL after the incident, requirement for transfusion of ≥ 2 units of packed read blood cells, or intracranial, intraspinal, intraocular, pericardial, retroperitoneal, intramuscular causing compartment syndrome, or fatal bleeding. | From the date of index VTE to MB occurrence, assessed up to 12 months |
| Clinical Relevant Non Major Bleeding (CRNMB) | CRNMB was defined as overt bleeding not meeting the criteria for MB but associated with medical intervention, unscheduled contact with a member of the health care team, temporary cessation of the treatment, or impairment of activities of daily life. | From the date of index VTE to CRNMB occurrence, assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Deaths, regardless of the mechanism, were included in the all-cause mortality outcome | One year follow up since index VTE identified until the date of death from any cause, whichever came first, , assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.
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Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment at The Sixth Affiliated Hospital, Sun Yat-sen University from January 2019 to January 2023. VTE was considered cancer-related if the patient had a diagnosis of CRC within six months before or after the VTE diagnosis, any cancer treatment within the previous six months, or recurrent/metastatic cancer regardless of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| xiaoyan li | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Sixth Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D003110 | Colonic Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| D015179 |
| Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |