RecruitingNot ApplicableNCT06708572
Evaluation of the Use of Granulocyte Colony Stimulating Factor (GCSF) in Post Kasai Type 3 Biliary Atresia
Sponsor
National Liver Institute, Egypt
Enrollment
40 participants
Start Date
Dec 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of the study is to evaluate the use of Granulocyte Colony Stimulating Factor (GCSF) on the clinical and biochemical outcome of type 3 biliary atresia post kasai.
Eligibility
Min Age: 20 DaysMax Age: 1 Year
Inclusion Criteria1
- Infants with initial diagnosis of biliary atresia with biliary atresia score \> 23.927 will be allocated for Kasai porto-enterostomy with intra-operative cholangiogram reaching type 3 biliary atresia anatomy as a final diagnosis.
Exclusion Criteria6
- Major cardiac, renal, pulmonary, neurological malformations or illnesses.
- Hemoglobinopathies, such as sickle cell anemia
- Active systemic infection.
- White blood cell count \> 20,000 cells/mm3.
- Platelet count \< 40,000 cells/mm3 or ≥ 800,000 cells/mm3.
- Purpura fulminans or unexplained vascular thrombotic conditions.
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Interventions
DRUGGranulocyte Colony-Stimulating Factor
20 patients will receive subcutaneous GCSF at a daily dose of 10ug/kg for 3 consecutive days. It is administered within 3-4 days after the Kasai procedure.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06708572
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