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

Mayo Clinic

Status: Completed

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

Treatments: Other: Electronic Health Record Review; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05053100

MC210804 (Other Identifier)

NCI-2021-09154 (Registry Identifier)

20-006940 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Observational (record review, blood collection)

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Other: Electronic Health Record Review