Clinical trial NCT05053100: Understanding the Risk of Blood Clots and Bleeding in Patients With Hematological Malignancies, HAT Study
Official title: Hemorrhage and Thrombosis in Hematology Malignancies: Understanding the Risks of Thrombosis and Anticoagulation in Patients With Hematologic Malignancies (HAT Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Deep Vein Thrombosis
Hematopoietic and Lymphoid Cell Neoplasm
Hodgkin Lymphoma
Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma
Plasma Cell Myeloma
Thrombocytopenia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Mayo Clinic Arizona Hematology.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thrombosis incidence
timeFrame: Up to 1 year
measure: Rate of venous thromboembolism (VTE) recurrence
timeFrame: Up to 1 year
Secondary outcomes:
measure: Hemorrhage incidence, without prior thrombosis
timeFrame: Up to 1 year
measure: Hemorrhage incidence, with prior thrombosis < 12 months
timeFrame: Within 3 months following deep vein thrombosis diagnosis
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Leslie J. Padrnos, MD
role: PRINCIPAL_INVESTIGATOR
References: