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

NCT05053100 | Completed

• 3 other identifiers: MC210804NCI-2021-0915420-006940
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Hemorrhage incidence, without prior thrombosis

  Up to 1 year

• Hemorrhage incidence, with prior thrombosis < 12 months

  Within 3 months following deep vein thrombosis diagnosis

Study Arms (1)

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; Other: Electronic Health Record Review

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection

Observational (record review, blood collection)

Electronic Health Record Review OTHER

Undergo electronic health record review

Observational (record review, blood collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Mayo Clinic Arizona Hematology.

You may qualify if:

• 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

You may not qualify if:

• Solid tumor malignancy patients
• Age \< 18

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Venous Thrombosis; Hematologic Neoplasms; Hodgkin Disease; Myeloproliferative Disorders; Lymphoma, Non-Hodgkin; Multiple Myeloma; Thrombocytopenia

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Cytopenia

Study Officials

• Leslie J. Padrnos, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: August 17, 2021
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)