Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding

NCT06947044 | Recruiting

• 1 other identifier: 15529
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

transfusion; red blood cells; hemoglobin level; bleeding

Outcome Measures

Primary Outcomes (5)

• Effect of maintaining a higher hemoglobin level (110 g/L) compared with the standard hemoglobin level on bleeding-related biomarkers.

  Blood and urine samples will be taken from participants at selected timepoints to measure levels of biomarkers from the endothelial integrity, inflammation, and fibrinolysis/coagulation domains.

  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)

  The total number of days where hemoglobin levels were above the assigned threshold or days where RBCs were administered when the hemoglobin level was reported to be below that threshold.

  Day 1 to 30

• Protocol adherence to the study schedule (feasibility outcome)

  Measurement of how consistently participants and study staff follow the prescribed schedule for study assessments and sample collections as outlined in the study protocol. Measurements include percentage of scheduled biomarker testing days with data collected, percentage of non-weekday study days with completed bleeding assessments, and percentage of scheduled study days with completed FACT questionnaires.

  Day 1 to 30

• Consent rate (feasibility outcome)

  The proportion of potential participants who agree to participate in the study.

  Through study completion, an average of 1.5 years

• Screen failure rate (feasibility outcome)

  The proportion of participants who are screened for eligibility but do not meet the study's inclusion and exclusion criteria and are therefore not enrolled in the trial.

  Through study completion, an average of 1.5 years

Secondary Outcomes (3)

• The total number of blood products administered to participants in the liberal and standard arms of the study

  Day 1 to 30

• The association between the hemoglobin threshold used and bleeding events

  Day 1 to 30

• The association between the hemoglobin threshold used and quality-of-life

  Assessed weekly, from before chemotherapy onset to day 28

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: RBC transfusion strategy

Standard-of-care RBC transfusion strategy

NO INTERVENTION

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 PROCEDURE

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

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

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.
• Inpatient
• Diagnosis of acute myeloid leukemia or acute lymphocytic leukemia.
• Less than 5 days have elapsed since the start of induction chemotherapy treatment.
• Hemoglobin at enrolment is under 130 g/L.

You may not qualify if:

• Failure to provide informed consent.
• Unwilling to receive blood transfusions.
• Life expectancy \<72 hours.
• Undergoing palliative chemotherapy.
• Requires specialized blood products (e.g., antigen-matched, irradiation, etc.).
• Diagnosis of acute promyelocytic leukemia.
• Diagnosis of hyperleukocytosis (a white blood cell count exceeding 100 × 10\^9/L).
• 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)
• Evidence of iron overload (ferritin \>800 ng/mL, transferrin saturation \>80%) .

Sponsors & Collaborators

• Donald Arnold: lead

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hemorrhage

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dimpy Modi

CONTACT

905-525-9140; modid1@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 27, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

CA (1)