Clinical Trial

Venous Thromboembolism in Hematologic Malignancy and Hematopoietic Cell Transplant Patients: a Retrospective Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 27, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer, after disease progression. VTE is increasingly recognized as a complication in patients with hematologic malignancies and various studies have reported high rates of VTE. Critically ill patients are at high risk of VTE and should all receive thromboprophylaxis. Given the increasing number of patients with HM (hematologic malignancies) / HCT (Hematopoietic cell transplantation) who develop critical illness, and their often prolonged course, it is imperative to understand the incidence and risk factors for VTE, and to evaluate the efficacy and risks associated with both chemical and mechanical thromboprophylaxis Therefore, the investigators plan to evaluate retrospectively the VTE / PE (pulmonary embolism) incidence in HM /HCT patients at the University of Toronto, and the complications associated with it (including death). In addition, the investigators want to evaluate the use, type (mechanical or pharmacological) and timing of thromboprophylaxis. And lastly, the investigators will determine the incidence of bleeding and of complications associated with chemical and mechanical thromboprophylaxis. The investigators will describe the change in VTE incidence over the last 10 years. The investigators know that patients with COVID-19 infection are at higher risk of thrombosis than non-COVID patients. As such, HM/HCT COVID-19 pts will comprise a subgroup, which will be compared with patients who are not not positive for COVID-19. If these numbers are low, COVID-19 status will be included as a predictive variable in our modelling. The results of this research program will help define indications and safety of VTE prophylaxis; and will inform the development of clinical practice guidelines.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-05-24; most recent amendment 2024-11-25.
Status change: Recruiting → Active, Not Recruiting 2022-11-21
Trial Details
NCT Number NCT05396157
Lead Sponsor Mount Sinai Hospital, Canada
Conditions Thrombosis, Venous, Bleeding Hemorrhage, Venous Thromboembolic Disease, Hematologic Malignancy, Thrombocytopenia
Enrollment 813 participants
Start Date 2021-11-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-27