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

Recruiting

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

• Registration Number: NCT05053100
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-08-18
• Study Completion: 2025-08-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Solid tumor malignancy patients
• Age < 18

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (record review, blood collection)	Electronic Health Record Review	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.
Observational (record review, blood collection)	Biospecimen 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.

Primary Outcome Measures

Name	Time	Method
Rate of venous thromboembolism recurrence	Up to 1 year	Kaplan-Meier curve is created and compared by anticoagulation strategy.
Thrombosis incidence	Time between admission to the hospital and venous thrombotic event, assessed up to 1 year

Secondary Outcome Measures

Name	Time	Method
Hemorrhage incidence, without prior thrombosis	Time between admission to the hospital and hemorrhage event, assessed up to 1 year
Hemorrhage incidence, with prior thrombosis < 12 months	Within 3 months following deep vein thrombosis diagnosis

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States