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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05053100
Other study ID # MC210804
Secondary ID NCI-2021-09154
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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