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

NCT ID: NCT07062250

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-03-31

Brief Summary

The aim is to investigate the feasibility, safety, and complication rates of patient's self-measurement of CBC and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.

This study is a single-arm feasibility study with patients newly diagnosed with Acute Myeloid Leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.

Patients are included if they are ≥ 18 years old, newly diagnosed with AML within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based CBC measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.

Included patients will receive comprehensive training and certification to perform CBC measurements, self-administer transfusions, and monitor selected vital parameters including blood pressure, pulse rate, oxygen saturation, and temperature.

It is hypothesized that the study can demonstrate the logistic, technical, and economic feasibility and safety of educating patients with AML undergoing intensive chemotherapy, to independently conduct self-measurement of complete blood count (CBC), self-administration of transfusions at home, and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion.

Detailed Description

Acute Myeloid Leukemia is a serious blood cancer treated with intensive chemotherapy. Around 150 patients in Denmark receive such treatment annually. Each patient undergoes 2-4 chemotherapy cycles, each followed by a 3-4 week period of bone marrow suppression, requiring frequent blood and platelet transfusions and increasing infection risk. Patients with acute myeloid leukemia, experience prolonged chemotherapy-induced pancytopenia, lasting between 2 to 4 weeks. In our existing outpatient treatment setup, patients visit the day hospital 3 times weekly for blood measurements, clinical evaluation, and transfusions with blood and platelets.

Transfusion reactions are rare, and serious complications are even less common. While some studies have explored home transfusions administered by healthcare professionals or relatives, no studies have examined self-administered home transfusions.

Patient involvement is increasingly important in cancer care. Understanding patient experiences is key to implementing safe and successful home-based care, especially in long-term, intensive treatments. Maintaining daily life and being with loved ones during treatment are highly valued by patients and families.

In this study, we aim to instruct patients to perform complete blood count measurements and self-administration of transfusions at home, thereby reducing the need for weekly visits to the hospital. However, patients will still be required to come into the hospital for blood measurements, clinical control with their responsible physician, and transfusions once weekly.

Objective To investigate the feasibility, safety, and complication rates of patients self-measurement of complete blood count and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.

Design and methods This study is a single-arm feasibility study with patients newly diagnosed with acute myeloid leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.

Participants Patients are included if they are ≥ 18 years old, newly diagnosed with acute myeloid leukemia within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based complete blood count measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.

Recruitment and Procedure Patients, n= 15 will be recruited at the outpatient clinic at the Department of Hematology, Rigshospitalet.

We will develop an educational program to facilitate certification of the patients for complete blood count self-measurements and transfusion administration. The development of the educational program will adhere to the framework outlined by the Medical Research Council for the development and evaluation of complex interventions. This education will be performed shortly after obtaining informed consent at the day hospital clinic.

The patients will receive training in drawing blood from their central venous catheter into an EDTA anticoagulated tube and in how to use HemoscreenTM. Hemoglobin and platelet values will be used to determine the need for blood and platelet transfusions. The patients will then be responsible for self-administering the blood products at the hospital under supervision by health care professionals. Patients will also learn how to administer antihistamines, acetaminophen, corticosteroids, and epinephrine either orally, subcutaneously, or intravenously following guidance from healthcare professionals at the department.

Before and after the transfusions, patients will measure their own blood pressure, pulse rate, temperature, and saturation, which is the same procedure nurses perform in relation to transfusion of blood products.

At home, patients will be responsible for independently conducting complete blood count measurements, administering transfusions, and monitoring selected vital parameters before and after transfusions, fostering their active involvement and empowerment in their treatment trajectory. Nurses at the department can always be contacted for questions and guidance. Patients will be instructed to contact the nurses in the day hospital clinic in the daytime, and the hematological ward in the evening and at night. Complete blood counts will be measured on the Hemoscreen instrument, which will feature a digital interface that allows the transfer of test results to the patient's electronic medical record at the hospital.

Conditions

Acute Myeloid Leukaemia (AML)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Feasibility

Feasibility and safety of home-based blood count measurement and transfusions

Group Type: EXPERIMENTAL

Feasibility and safety of home-based blood count measurement and transfusions

Intervention Type: DEVICE

Feasibility and safety of home-based blood count measurement and transfusions in patients with acute myeloid leukemia

Interventions

Feasibility and safety of home-based blood count measurement and transfusions

Feasibility and safety of home-based blood count measurement and transfusions in patients with acute myeloid leukemia

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old
• newly diagnosed with AML within four weeks
• scheduled to receive home-based chemotherapy.

Exclusion Criteria

• Patients who do not understand or speak Danish
• Incapable of performing home-based CBC measurements and administration of transfusions.
• Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Iben Husted Nielsen

Clinical nurse specialist, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Kjeldsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Iben H Nielsen, PhD

Role: CONTACT

iben.husted.nielsen@regionh.dk

+4526227757

Lars Kjeldsen, MD

Role: CONTACT

lars.kjeldsen.01@regionh.dk

+4530224032

Facility Contacts

Iben H Nielsen, Clinical Nurse Specialist, PhD

Role: primary

iben.husted.nielsen@regionh.dk

+4526227757

Lars Kjeldsen, Consultant, MD

Role: backup

lars.kjeldsen.01@regionh.dk

+4530224032

Other Identifiers

p-2023-14481

Identifier Type: -

Identifier Source: org_study_id