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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09154 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20-006940 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (record review, blood collection) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis incidence | Assessed by incidence of hemorrhage following deep vein thrombosis diagnosis, based on anticoagulant use and presence of thrombocytopenia | Up to 1 year |
| Rate of venous thromboembolism (VTE) recurrence | Assessed as the time from admission to the hospital and Venous thrombotic event | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhage incidence, without prior thrombosis | Assessed as the time from admission to the hospital until hemorrhage incidence (without prior thrombosis) | Up to 1 year |
| Hemorrhage incidence, with prior thrombosis < 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to Mayo Clinic Arizona Hematology.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie J. Padrnos, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Electronic Health Record Review | Other | Undergo electronic health record review |
|
Assessed as the time from admission to the hospital until Hemorrhage incidence (with prior thrombosis) < 12 months
| Within 3 months following deep vein thrombosis diagnosis |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D019337 | Hematologic Neoplasms |
| D006689 | Hodgkin Disease |
| D009196 | Myeloproliferative Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
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