Acute Leukemia, Deep Vein Thrombosis, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Thrombocytopenia
Conditions
Brief summary
This study evaluates the risks and experience of blood clots and bleeding in patients with blood cancers. While it is standard of care to use medications to reduce the risk of blood clots in hospitalized individuals, some patients with blood cancers have low platelet counts that can increase the concern for bleeding complications associated with these medications. At this time, the optimal management strategies for blood clots are not well known for patients with blood cancers. This pilot study evaluates additional information that could help doctors know which patients are at highest risk for blood clots.
Detailed description
PRIMARY OBJECTIVES: I. Determine the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia. II. Determine recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia. SECONDARY OBJECTIVES: I. Assess feasibility of database creation of patient and clinical characteristics regarding thrombosis and hemorrhage in hospitalized malignant hematology patients. II. Assess feasibility of patient enrollment and hemostatic laboratory collection pre, during and post treatment. III. Describe the impact of thrombocytopenia on resource utilization following thrombosis diagnosis (blood product administration, imaging studies performed, number of days hospitalized). IV. Describe the impact of therapeutic anticoagulation vs prophylactic anticoagulation on resource utilization following thrombosis diagnosis (blood product administration, imaging studies performed, number of days hospitalized). V. Define baseline hemostatic characteristics in hospitalized malignant hematology patients prior to chemotherapy and the association with thrombosis or hemorrhage. VI. Describe changes in laboratory hemostatic characteristics pre-treatment, during treatment and post treatment. OUTLINE: Patients' electronic health record are reviewed for 12 months and/or undergo collection of blood at pretreatment and on days 7, 28, 90, and 180.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood
OTHERElectronic Health Record Review
Undergo electronic health record review
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All unique patients, age \> 18 years old, admitted to the Mayo Clinic Arizona Hematology A and B Service for initiation of 1.) new (or next line) chemotherapy, 2.) autologous stem cell transplant, or 3.) allogeneic stem cell transplant for a hematologic malignancy
Exclusion criteria
* Solid tumor malignancy patients * Age \< 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis incidence | Up to 1 year | Assessed by incidence of hemorrhage following deep vein thrombosis diagnosis, based on anticoagulant use and presence of thrombocytopenia |
| Rate of venous thromboembolism (VTE) recurrence | Up to 1 year | Assessed as the time from admission to the hospital and Venous thrombotic event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhage incidence, with prior thrombosis < 12 months | Within 3 months following deep vein thrombosis diagnosis | Assessed as the time from admission to the hospital until Hemorrhage incidence (with prior thrombosis) \< 12 months |
| Hemorrhage incidence, without prior thrombosis | Up to 1 year | Assessed as the time from admission to the hospital until hemorrhage incidence (without prior thrombosis) |
Countries
United States
Outcome results
None listed