Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07062250

Feasibility and Safety of Home Blood Count Measurement and Transfusions by Systematically Educated Patients With Acute Myeloid Leukemia

Led by Rigshospitalet, Denmark · Updated on 2025-07-14

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the feasibility, safety, and complication rates of patients with newly diagnosed Acute Myeloid Leukemia (AML) measuring their own complete blood counts (CBC) and administering blood and platelet transfusions at home. This single-arm feasibility study aims to explore how well patients can monitor vital signs like blood pressure, pulse rate, oxygen saturation, and temperature before and after transfusions. The study also evaluates the potential health economic benefits, such as reducing the need for nurse-driven services during intensive chemotherapy treatment. Participants receive training and certification to perform CBC measurements using the Hemoscreen instrument, self-administer transfusions at home, and monitor vital signs. They learn to draw blood from their central venous catheter and manage medications like antihistamines, acetaminophen, corticosteroids, and epinephrine under healthcare guidance. Although patients perform many tasks independently at home, they will still attend the hospital once weekly for clinical evaluations and transfusions, and have access to nursing support whenever needed. Throughout the study, patients' technical performance using the Hemoscreen device, ability to self-administer transfusions, and accuracy in monitoring vital signs are continuously recorded for up to 12 weeks. Researchers track any transfusion reactions, adverse events, extra healthcare visits, and hospital admissions. They also assess changes in quality of life and patient empowerment over the study period. This detailed monitoring helps evaluate both the safety and practicality of home-based self-care during intensive AML treatment.

CONDITIONS

Brief Title

Feasibility and Safety of Home Blood Count Measurement and Transfusions in Patients With Acute Myeloid Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Newly diagnosed with Acute Myeloid Leukemia within four weeks
  • Scheduled to receive home-based chemotherapy
Not Eligible

You will not qualify if you...

  • Do not understand or speak Danish
  • Unable to perform home-based complete blood count measurements and transfusions
  • Discontinued if remission is not achieved after the second chemotherapy cycle

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at the outpatient clinic

Training and Certification

Duration - Shortly after screening and enrollment

Participants receive education and training on how to perform complete blood count measurements and self-administer blood and platelet transfusions at home, including vital signs monitoring before and after transfusions.

1 training visit at the day hospital clinic

Treatment

Duration - Up to 12 weeks

Participants undergo up to 2 to 4 chemotherapy cycles with home-based blood count measurements and self-administered transfusions, while attending the hospital once weekly for clinical evaluations and transfusions under supervision.

Weekly hospital visits for blood measurements, clinical evaluation, and supervised transfusions; self-administered blood count measurements and transfusions at home continuously

Follow-up

Duration - Up to 12 weeks during treatment

Monitoring for transfusion reactions, adverse events, and health outcomes continues throughout the treatment period with ongoing support available from healthcare providers.

Continuous monitoring with contact to nurses as needed

Trial Site Locations

Total: 1 location

1

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

I

Iben H Nielsen, PhD

L

Lars Kjeldsen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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