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A study to determine how granulocyte (a type of white blood cell) transfusion helps children with cancer suffering from severe bacterial infection.

A phase II randomised, open label study to determine the efficacy of granulocyte transfusion amongst paediatric cancer patients with carbapenem-resistant gram-negative sepsis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049667
Enrollment
89
Registered
2023-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: C91- Lymphoid leukemia Health Condition 2: C92- Myeloid leukemia Health Condition 3: D701- Agranulocytosis secondary to cancer chemotherapy

Interventions

Intervention1: Granulocyte Transfusion: Patients will receive antibiotics and other supportive care measures as per departmental policy with granulocytes.The granulocyte product will be infused throug
the prospective granulocyte donor will thus not be primed the previous evening. Overall recovery will be defined as the first of two consecutive days with an ANC 1000 cells/ ? L without granulocyte s

Sponsors

TATA MEMORIAL HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: I. Children 1-18 years of age II. Subjects diagnosed and treated with hematolymphoid neoplasm. III. ANC 5 days IV. Carbepenem resistant gram-negative sepsis

Exclusion criteria

Exclusion criteria: I. Any subject requiring more than fluid boluses (20ml/kg) to correct hypotension II. Any subject admitted in intensive care unit III. Any subject with ejection fraction IV. Any subject with necrotizing enterocolitis V. Any subject diagnosed with solid tumor VI. Subjects previously enrolled in this study

Design outcomes

Primary

MeasureTime frame
1. To estimate the effect of granulocyte transfusion on 30 day mortality 2. To estimate the effect of granulocyte transfusion on ICU transferTimepoint: Thirty days from the day of Granulocyte administration

Secondary

MeasureTime frame
1.To assess the time to fever resolution in hours 2.To determine the time to negative blood culture in days 3.To evaluate the length of hospital stay in days 4.To assess adverse events due to granulocyte infusionTimepoint: From the day of enrolment in the study till discharge from hospitalization

Countries

India

Contacts

Public ContactDr SHYAM SRINIVASAN

Tata Memorial Hospital, Mumbai

srinivas.shyam@gmail.com9619983999

Outcome results

None listed

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