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The impact of strict and relaxed red blood cell infusion strategies on chemotherapy related serious adverse reactions in children with acute leukemia - a multicenter crossover design randomized controlled trial

The impact of strict and relaxed red blood cell infusion strategies on chemotherapy related serious adverse reactions in children with acute leukemia - a multicenter crossover design randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088565
Enrollment
Unknown
Registered
2024-08-21
Start date
2024-09-09
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphoblastic leukemia

Interventions

restrictive red blood cell transfusion strategy:After enrollment, routine blood tests will be performed to monitor the patients' hemoglobin levels. If the recorded hemoglobin level is =60 g/L, red blo
liberal red blood cell transfusion strategy:After enrollment, routine blood tests will be performed regularly to monitor the patients' hemoglobin levels. If the recorded hemoglobin value is =70 g/L, r

Sponsors

the Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Children diagnosed with acute lymphoblastic leukemia (ALL) who are eligible for treatment under the 2020 or 2018 protocols of the Chinese Children's Oncology Group (CCCG); (2) Following induction chemotherapy and achievement of remission (VDLP or VDLD) for newly diagnosed acute lymphoblastic leukemia; (3) Aged between 1 year and 18 years inclusive.

Exclusion criteria

Exclusion criteria: (1) Patients deemed unsuitable by their attending physicians for either the stringent or liberal red blood cell (RBC) transfusion strategy, such as those with congenital heart disease, active bleeding or hemodynamic instability, known contraindications to RBC transfusion (e.g., severe transfusion reactions or hemolytic transfusion reactions), severe pneumonia with inadequate oxygenation, relapsed leukemia, or other conditions that may compromise the safety or validity of the study. (2) Children who are planned to undergo hematopoietic stem cell transplantation (HSCT) in the short term. (3) Children who are unable to provide informed consent or participate in the study due to any reason, such as cognitive impairment, inadequate language proficiency, or lack of legal guardian approval.

Design outcomes

Primary

MeasureTime frame
Event-free survival;Overall survival;

Secondary

MeasureTime frame
Duration of IV grade bone marrow suppression;Quality of Life;

Countries

China

Contacts

Public ContactRong Gui

the Third Xiangya Hospital, Central South University,

600957@csu.edu.cn+86 139 7519 9279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026