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

NCT05396157 | Active Not Recruiting

• 1 other identifier: CariniDVT2021
• Study Type: observational
• Target: 813
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombosis, Venous; Bleeding Hemorrhage; Venous Thromboembolic Disease; Hematologic Malignancy; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• VTE

  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

  Through study completion, an average of 1 month

Secondary Outcomes (3)

• Thromboprophylaxis use

  Through study completion, an average of 1 month

• Bleeding

  Through study completion, an average of 1 month

• Outcome

  Through study completion, an average of 1 month

Study Arms (1)

Patients with an active hematological malignancy admitted to ICU

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)

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

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients not admitted to the ICU, even though they had a diagnosis of HM / HCT.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Federico Carini

Toronto, Ontario, M4Y 1G3, Canada

Location

Related Publications (7)

• Cushman 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 BACKGROUND

• Farge 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 BACKGROUND

• Chaturvedi 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 BACKGROUND

• Pachon 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 BACKGROUND

• Dhakal 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 BACKGROUND

• Schulman 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.

  PMID: 15842354 BACKGROUND

• Carini FC, Munshi L, Novitzky-Basso I, Dozois G, Heredia C, Damouras S, Ferreyro BL, Mehta S. Incidence of venous thromboembolic disease and risk of bleeding in critically ill patients with hematologic malignancies: A retrospective study. Med Intensiva (Engl Ed). 2024 Nov;48(11):e1-e9. doi: 10.1016/j.medine.2024.06.003. Epub 2024 Jun 21.

  PMID: 38906793 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Hemorrhage; Hematologic Neoplasms; Thrombocytopenia

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Cytopenia

Study Design

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

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: May 31, 2022
• Study Start: November 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)