About this trial
The goal of this clinical trial is to have a successful engraftment in after bone transplantation. Acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. Primary hypothesis is Patients receiving SMOF LIPID will have better grafts than patients receiving intralipid. Also, complications after surgery and malnutrition will be less in this group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness to cooperate and complete the informed consent form by the legal guardian of the child;
Age ≤ 18 years;
Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation;
Eligible for parenteral nutrition support;
Disqualifiers
Death of the child earlier than 5 days from the start of the intervention;
Unwillingness to continue cooperation during study;
Occurrence of side effects during the study;
In case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.
Trial design
Parallel
Treatments tested in this trial
SMOF lipid
Dietary supplementThe SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
INTRALIPIDS
Dietary supplementThe Intralipid will be given to the patient as fat component of total parenteral nutrition.
Treatment groups
Trial outcomes
Primary outcomes
Engraftment
blood counts of Neutrophils and platelets
Secondary outcomes
100-day survival rate
Determination and comparison of 100-day survival rate after transplantation in both groups
Incidence of infection
Determining and comparing the incidence of infection
Incidence of bleeding
Determining and comparing the incidence of bleeding
Hospitalization
Determining and comparing the duration of hospitalization in both groups
Sponsors and contacts
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