Clinical trial · Observational
Venous Thromboembolism in Hematologic Malignancy and Hematopoietic Cell Transplant Patients: a Retrospective Study
Venous Thromboembolism in Hematologic Malignancy and Hematopoietic Cell Transplant Patients: a Retrospective Study of Thrombosis / Bleeding Incidence and Prophylaxis Trends
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding Hemorrhage | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Thrombocytopenia | — | UNRESOLVED | — |
| Thrombosis, Venous | — | UNRESOLVED | — |
| Venous Thromboembolic Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with an active hematological malignancy admitted to ICU
- description
- All patients 18 years and older admitted to an adult intensive care unit during the current admission episode and that also had an active HM / HCT diagnosis. We plan to the analyze patients outcomes according to: 1. Thrombocytopenia We will analyze bleeding and thrombosis risk taking into account platelets levels. 2. Patients receiving thromboprophylaxis (VTE vs Bleeding)
Primary outcomes (1)
- measure
- VTE
- timeFrame
- Through study completion, an average of 1 month
- description
- The primary outcome will be the number of patients who suffered a catheter and non catheter related VTE (upper/lower extremity DVT and PE) during their ICU admission. For DVT diagnosis venous ultrasonography is the first-line imaging test. Alternative imaging modalities will include computed tomographic imaging, magnetic resonance (MR) imaging, and contrast computed tomography (CT)(12). For the diagnosis of PE, confirmatory imaging (i.e., CT pulmonary angiography, ventilation-perfusion scan) will be required for definitive diagnosis
Secondary outcomes (3)
- measure
- Thromboprophylaxis use
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients 18 years and older admitted to an adult intensive care unit during the current admission episode and that also had an active HM / HCT diagnosis. Exclusion Criteria: * Patients not admitted to the ICU, even though they had a diagnosis of HM / HCT.
References
Publications (7)
- BACKGROUNDCushman M. Epidemiology and risk factors for venous thrombosis. Semin Hematol. 2007 Apr;44(2):62-9. doi: 10.1053/j.seminhematol.2007.02.004. PMID 17433897
- BACKGROUNDFarge D, Frere C, Connors JM, Ay C, Khorana AA, Munoz A, Brenner B, Kakkar A, Rafii H, Solymoss S, Brilhante D, Monreal M, Bounameaux H, Pabinger I, Douketis J; International Initiative on Thrombosis and Cancer (ITAC) advisory panel. 2019 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer. Lancet Oncol. 2019 Oct;20(10):e566-e581. doi: 10.1016/S1470-2045(19)30336-5. Epub 2019 Sep 3. PMID 31492632
- BACKGROUNDChaturvedi S, Neff A, Nagler A, Savani U, Mohty M, Savani BN. Venous thromboembolism in hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2016 Apr;51(4):473-8. doi: 10.1038/bmt.2015.308. Epub 2015 Dec 21. PMID 26691425
- BACKGROUNDPachon V, Trujillo-Santos J, Domenech P, Gallardo E, Font C, Gonzalez-Porras JR, Perez-Segura P, Maestre A, Mateo J, Munoz A, Peris ML, Lecumberri R. Cancer-Associated Thrombosis: Beyond Clinical Practice Guidelines-A Multidisciplinary (SEMI-SEOM-SETH) Expert Consensus. TH Open. 2018 Nov 5;2(4):e373-e386. doi: 10.1055/s-0038-1675577. eCollection 2018 Oct. PMID 31249964
- BACKGROUNDDhakal P, Wang L, Gardiner J, Shrotriya S, Sharma M, Rayamajhi S. Effectiveness of Sequential Compression Devices in Prevention of Venous Thromboembolism in Medically Ill Hospitalized Patients: A Retrospective Cohort Study. Turk J Haematol. 2019 Aug 2;36(3):193-198. doi: 10.4274/tjh.galenos.2019.2018.0413. Epub 2019 May 1. PMID 31042860
- BACKGROUNDSchulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.