Understanding the Risk of Blood Clots and Bleeding in Patients With Hematological Malignancies, HAT Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hemorrhage and Thrombosis in Hematology Malignancies: Understanding the Risks of Thrombosis and Anticoagulation in Patients With Hematologic Malignancies (HAT Trial)

Conditions
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Thrombocytopenia, Acute Leukemia, Deep Vein Thrombosis, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma, Plasma Cell Myeloma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (record review, blood collection)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of blood<br>* Other names: Biological Sample Collection;Other: Electronic Health Record Review<br>* Undergo electronic health record review<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis incidence |  | Time between admission to the hospital and venous thrombotic event, assessed up to 1 year | 
| Rate of venous thromboembolism recurrence | Kaplan-Meier curve is created and compared by anticoagulation strategy. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhage incidence, without prior thrombosis |  | Time between admission to the hospital and hemorrhage event, assessed up to 1 year | 
| Hemorrhage incidence, with prior thrombosis < 12 months |  | Within 3 months following deep vein thrombosis diagnosis |