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

NCT07062250 | Recruiting

• 1 other identifier: p-2023-14481
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukaemia (AML)

Keywords

Home transfusion; Hematology; Blood transfusion; Home based treatment; Acute leukemia; Patient empowerment

Outcome Measures

Primary Outcomes (8)

• Technical Performance of the Hemoscreen Instrument

  Number and classification of technical issues encountered by patients using the Hemoscreen instrument, including device malfunctions, failures, and errors in transmission of complete blood count (CBC) measurements. Recorded per transfusion event through hospital records and patient reports; categorized by issue type (e.g., hardware failure, data transmission error).

  Assessed throughout each participant's enrollment period, up to 12 weeks.

• Self-Administered Blood Measurements at Home

  Number of CBC measurements performed by patients at home using the Hemoscreen instrument. Extracted from hospital records and participants' self-reporting.

  Recorded continuously during each participant's enrollment, up to 12 weeks.

• Self-Administered Blood and Platelet Transfusions at Home

  Number of blood and platelet transfusions self-administered at home without direct hospital supervision. Extracted from hospital records and participants' self-reporting.

  Recorded continuously during each participant's enrollment, up to 12 weeks.

• Replacement of Scheduled Day Hospital Visits by Home Care and Self-Testing

  Number of scheduled day hospital visits replaced by successful self-testing and home transfusions. Determined by comparing hospital visit records with home care study documentation.

  Recorded continuously during each participant's enrollment, up to 12 weeks.

• Vital Signs Before and After Home Transfusions

  Vital parameters including temperature (°C), pulse rate (beats per minute), and blood pressure (mmHg) measured immediately before and after each home transfusion. Measurement: Collected by participants using standardized home monitoring devices and confirmed during nursing visits.

  Recorded at each home transfusion event during the participant's 12-week enrollment.

• Extra Healthcare Visits and Hospital Admissions

  Number, cause, and duration (days) of unplanned extra visits to the day hospital or inpatient ward related to transfusion or device complications. Data collected from hospital records.

  Recorded continuously during each participant's enrollment, up to 12 weeks.

• Transfusion Reactions and Adverse Events

  Number and severity of transfusion reactions, including serious infusion reactions necessitating hospital admission. Documented by clinicians and participant self-reporting; hospital admissions verified through records.

  Assessed continuously during and for 24 hours post-transfusion within each participant's study period, up to 12 weeks.

• Types of Transfusion Reactions

  Frequency and types of transfusion reactions, categorized as fever, shivering, hypotension, hypertension, hives, nausea, pain, malaise, allergic reactions, or others. Recorded using a standardized transfusion reaction form during clinical assessments and participant self-reports.

  Recorded at each transfusion event during each participant's enrollment up to 12-week study period.

Secondary Outcomes (2)

• Change in Quality of Life scores from EORTC QLQ-C30 at baseline and post-second chemotherapy

  Assessed over the course of each participant's study period, approximately 12 weeks.

• Empowerment

  Assessed over the course of each participant's study period, approximately 12 weeks.

Study Arms (1)

Feasibility

EXPERIMENTAL

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

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

Interventions

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

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

Feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Patient Participation

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Lars Kjeldsen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iben H Nielsen, PhD

CONTACT

+4526227757; iben.husted.nielsen@regionh.dk

Lars Kjeldsen, MD

CONTACT

+4530224032; lars.kjeldsen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nurse specialist, PhD

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 14, 2025
• Study Start: April 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)