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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053100
• Other study ID #: MC210804
• Secondary ID: NCI-2021-09154
• Status: Recruiting
• Start date: August 17, 2021
• Est. completion date: August 18, 2025

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 18, 2025
• Est. primary completion date: August 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Leukemia
• Deep Vein Thrombosis
• Hematopoietic and Lymphoid Cell Neoplasm
• Hodgkin Lymphoma
• Lymphoma
• Multiple Myeloma
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Non-Hodgkin Lymphoma
• Plasma Cell Myeloma
• Thrombocytopenia
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood

Other:
• Electronic Health Record Review
Undergo electronic health record review

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombosis incidence		Time between admission to the hospital and venous thrombotic event, assessed up to 1 year
Primary	Rate of venous thromboembolism recurrence	Kaplan-Meier curve is created and compared by anticoagulation strategy.	Up to 1 year
Secondary	Hemorrhage incidence, without prior thrombosis		Time between admission to the hospital and hemorrhage event, assessed up to 1 year
Secondary	Hemorrhage incidence, with prior thrombosis < 12 months		Within 3 months following deep vein thrombosis diagnosis