A study to determine how granulocyte (a type of white blood cell) transfusion helps children with cancer suffering from severe bacterial infection.
Phase 2
- Conditions
- Health Condition 1: D701- Agranulocytosis secondary to cancer chemotherapyHealth Condition 2: C91- Lymphoid leukemiaHealth Condition 3: C92- Myeloid leukemia
- Registration Number
- CTRI/2023/02/049667
- Lead Sponsor
- TATA MEMORIAL HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
I. Children 1-18 years of age
II. Subjects diagnosed and treated with hematolymphoid neoplasm.
III. ANC <500/mm3 with expected recovery period of >5 days
IV. Carbepenem resistant gram-negative sepsis
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 <20%
IV. Any subject with necrotizing enterocolitis
V. Any subject diagnosed with solid tumor
VI. Subjects previously enrolled in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To estimate the effect of granulocyte transfusion on 30 day mortality <br/ ><br>2. To estimate the effect of granulocyte transfusion on ICU transferTimepoint: Thirty days from the day of Granulocyte administration <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To assess the time to fever resolution in hours <br/ ><br>2.To determine the time to negative blood culture in days <br/ ><br>3.To evaluate the length of hospital stay in days <br/ ><br>4.To assess adverse events due to granulocyte infusionTimepoint: From the day of enrolment in the study till discharge from hospitalization