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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-17

Study Completion Date

2024-07-05

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Electronic Health Record Review

Intervention Type OTHER

Undergo electronic health record review

Interventions

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Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Electronic Health Record Review

Undergo electronic health record review

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection

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