Acute LeukemiaNCT05053100
Understanding the Risk of Blood Clots and Bleeding in Patients With Hematological Malignancies, HAT Study
An observational study of Acute Leukemia and Deep Vein Thrombosis, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Deep Vein Thrombosis, Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 5 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Mayo Clinic Arizona Hematology.
Who may be able to join
- 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
Who cannot join
- Solid tumor malignancy patients
- Age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- 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.
- Conditions
- Acute Leukemia, Deep Vein Thrombosis, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma
- Being tested
- Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- Venous Thrombosis, Hematologic Neoplasms, Hodgkin Disease, Myeloproliferative Disorders, Lymphoma, Non-Hodgkin, Multiple Myeloma, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo collection of blood
Electronic Health Record ReviewOther
Undergo electronic health record review
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis incidence
Assessed by incidence of hemorrhage following deep vein thrombosis diagnosis, based on anticoagulant use and presence of thrombocytopenia
Measured: Up to 1 year
Rate of venous thromboembolism (VTE) recurrence
Assessed as the time from admission to the hospital and Venous thrombotic event
Measured: Up to 1 year
Secondary outcomes (2)
Hemorrhage incidence, without prior thrombosis
Assessed as the time from admission to the hospital until hemorrhage incidence (without prior thrombosis)
Measured: 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
Measured: Within 3 months following deep vein thrombosis diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start17 Aug 2021
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie J. Padrnos, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053100
- Sponsor's protocol ID
- MC210804
- Other IDs
- NCI-2021-09154, 20-006940
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2021
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhage and Thrombosis in Hematology Malignancies: Understanding the Risks of Thrombosis and Anticoagulation in Patients With Hematologic Malignancies (HAT Trial)
- ClinicalTrials.gov ID
- NCT05053100
- Acronym / sponsor ID
- MC210804
- Conditions
- Acute Leukemia, Deep Vein Thrombosis, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (record review, blood collection) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients' electronic health record are reviewed for 12 months and/or undergo collection of blood at pretreatment and on days 7, 28, 90, and 180. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Mayo Clinic Arizona Hematology.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Solid tumor malignancy patients
- Age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo collection of blood | Procedure or surgery | Observational (record review, blood collection) |
| Electronic Health Record ReviewUndergo electronic health record review | Other | Observational (record review, blood collection) |
Primary outcome
Thrombosis incidence
Time frame: Up to 1 year
Assessed by incidence of hemorrhage following deep vein thrombosis diagnosis, based on anticoagulant use and presence of thrombocytopenia
Rate of venous thromboembolism (VTE) recurrence
Time frame: Up to 1 year
Assessed as the time from admission to the hospital and Venous thrombotic event
2 secondary outcomes
Hemorrhage incidence, without prior thrombosis
Time frame: Up to 1 year
Hemorrhage incidence, with prior thrombosis < 12 months
Time frame: Within 3 months following deep vein thrombosis diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie J. Padrnos, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and Deep Vein Thrombosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis incidence (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.