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

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

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Hodgkin Lymphoma; Thrombocytopenia; Deep Vein Thrombosis; Non-Hodgkin Lymphoma; Acute Leukemia; Plasma Cell Myeloma; Myeloproliferative Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Mayo Clinic Arizona Hematology.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Biospecimen Collection; Undergo collection of blood; Other Names: Biological Sample Collection; Other: Electronic Health Record Review; Undergo electronic health record review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Leslie J. Padrnos, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): July 5, 2024
• Study Completion (Actual): July 5, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Vascular Diseases; Cardiovascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Embolism and Thrombosis; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Neoplasms; Thrombosis; Venous Thrombosis; Lymphoma; Multiple Myeloma; Myeloproliferative Disorders; Thrombocytopenia
• Other Study ID Numbers: MC210804; NCI-2021-09154 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 20-006940 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No