Recruiting

Observational Study

Sponsor:

Donald Arnold

Code:

NCT06947044

Conditions

Acute Leukemia

Acute Myeloid Leukemia (AML)

Acute Lymphocytic Leukaemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RBC transfusion strategy

Study Details

Brief summary:

This pilot study aims to gather preliminary evidence on how different hemoglobin levels impact blood biomarkers related to bleeding. The feasibility of conducting a future larger clinical trial will also be assessed. Red blood cell transfusions are part of the standard of care for patients with leukemia. This study evaluates two transfusion strategies: one that maintains hemoglobin levels above the standard-of-care threshold, reflecting current routine practice; and another that maintains hemoglobin levels above 110 g/L, which is closer to the normal hemoglobin range. The normal hemoglobin range is 120-160 g/L for females and 140-180 g/L for males. Raising hemoglobin levels closer to normal values may reduce bleeding risk.

Conditions

Acute Leukemia

Acute Myeloid Leukemia (AML)

Acute Lymphocytic Leukaemia

Study ID

NCT06947044

Start date

Apr 11, 2025

Status verified date

Apr, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥18 years old.
2. Inpatient
3. Diagnosis of acute myeloid leukemia or acute lymphocytic leukemia.
4. Less than 5 days have elapsed since the start of induction chemotherapy treatment.
5. Hemoglobin at enrolment is under 130 g/L.

Exclusion Criteria:

1. Failure to provide informed consent.
2. Unwilling to receive blood transfusions.
3. Life expectancy <72 hours.
4. Undergoing palliative chemotherapy.
5. Requires specialized blood products (e.g., antigen-matched, irradiation, etc.).
6. Diagnosis of acute promyelocytic leukemia.
7. Diagnosis of hyperleukocytosis (a white blood cell count exceeding 100 × 10\^9/L).
8. Diagnosed with coagulopathies or ongoing treatment with therapeutic anticoagulants, aspirin or nonsteroidal anti-inflammatory drugs (history of inherited or acquired coagulation disorder, known hemolytic disease, INR > 1.5)
9. Evidence of iron overload (ferritin >800 ng/mL, transferrin saturation >80%) .

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL

Participants randomized to this arm will be assigned to a liberal RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.

no intervention: Standard-of-care RBC transfusion strategy

Participants randomized to this arm will be assigned to a restrictive RBC transfusion strategy of standard-of-care, which is typically to maintain a hemoglobin level of at least 70-80 g/L.

Interventions

RBC transfusion strategy

RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.

Primary outcome measure

  • Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers. [ Time Frame: Samples will be collected before chemotherapy onset, and on days 7, 14, and 28. The first day of chemotherapy is considered day 1 ]
  • Protocol adherence to the study intervention (feasibility outcome) [ Time Frame: Day 1 to 30 ]
  • Protocol adherence to the study schedule (feasibility outcome) [ Time Frame: Day 1 to 30 ]
  • Consent rate (feasibility outcome) [ Time Frame: Through study completion, an average of 1.5 years ]
  • Screen failure rate (feasibility outcome) [ Time Frame: Through study completion, an average of 1.5 years ]

Central Contacts and Locations

Central contacts

Dimpy Modi

905-525-9140modid1@mcmaster.ca

Locations

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contacts

Dimpy Modi

modid1@mcmaster.ca

More Information

Sponsor

Donald Arnold

Last update posted

Apr 27, 2025

Last verified

Apr, 2025

Keywords

  • transfusion
  • red blood cells
  • hemoglobin level
  • bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Donald Arnold on 2025-04-27.