Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism

NCT06440044 | Completed DMC

• 1 other identifier: 2024ZSLYEC-226
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombosis, Venous; Colo-rectal Cancer; Bleeding

Keywords

Venous Thrombembolism；Colorectal Cancer；Bleeding

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• All cause mortality

  One year follow up since index VTE identified until the date of death from any cause, whichever came first, , assessed up to 12 months

Study Arms (2)

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.

Other: Data collection

Patients without any adverse anticoagulant outcomes

Patients without any adverse anticoagulant outcomes in the study period.

Other: Data collection

Interventions

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.

Patients with adverse anticoagulant outcomes; Patients without any adverse anticoagulant outcomes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment.
• CRC patients with VTE treated with an anticoagulant (rivaroxaban or LMWH) for at least six months.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Venous Thrombosis; Colonic Neoplasms; Hemorrhage

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• xiaoyan li

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: January 1, 2019
• Primary Completion: June 16, 2024
• Study Completion: June 16, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)